Hydrogel Skin Dressing
FDA 510(k) K962352 · North American Sterilization & Packaging Co.
510(k) numberK962352
Submission
- Device name
- Hydrogel Skin Dressing
- Applicant
- North American Sterilization & Packaging Co.
Sparta, NJ, US - Received
- June 18, 1996
- Decision date
- August 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4022
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083721 | Modification to ZenievaNAE · Special | River'S Edge Pharmaceuticals, LLC | 01/08/2009SE |
| K082865 | Modification to ZenievaNAE · Special | Gorbec Pharmaceutical Services, Inc. | 10/23/2008SE |
| K073246 | ZenievaNAE · Traditional | Gorbec Pharmaceutical Services, Inc. | 07/23/2008SE |
| K992094 | Giltech Plus Hydrogel Skin DressingNAE · Traditional | Giltech Plus, Inc. | 09/17/1999SE |
| K991061 | Dermaphylyx Calcium Alginate Wound DressingNAE · Traditional | Dermaphylyx, Inc. | 06/28/1999SE |
| K972646 | Ad-Heal Hydrogel Dressing, Various SizesNAE · Traditional | Ludlow Technical Products | 08/21/1997SE |
| K971597 | Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903)NAE · Traditional | Coloplast Corp. | 07/29/1997SE |
| K952945 | Aquaflo Hydrogel Wound Dressing & PackerNAE · Traditional | Sherwood Medical Co. | 08/23/1995SN |
| K951166 | Bioderm Medical Hydrogel Island DressingNAE · Traditional | Bioderm, Inc. | 06/21/1995SE |
| K950412 | Curagel Hydrogel Wound DressingNAE · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 03/24/1995SE |
More from Kendall Healthcare Products Co. Div.Of Tyco Health
| 510(k) | Device | Decision |
|---|---|---|
| K964231 | Nasp Hydrocolloid Dressing (Regular or Thin)KMF · Traditional | 03/10/1997SE |
| K963753 | Nasp Transparent DressingMGP · Traditional | 11/29/1996SE |
| K925593 | Nortec Sterile Water for Device IrrigationLDQ · Traditional | 12/03/1993SE |
| K925588 | Nortec Ster SALINE-O.9% Sodium Chlor for Dev IrriLDQ · Traditional | 12/03/1993SE |
| K925161 | Nortec Sterile Water for Catheter Balloon InflatioKNY · Traditional | 07/21/1993SE |
| K911865 | Nortec Connecting Tube SetGAZ · Traditional | 11/01/1991SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 09/23/1991SE |
| K910691 | Nortec Ureteral StentFAD · Traditional | 08/15/1991SE |
| K903162 | Flexible Endoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
| K903156 | Control-Tip Cystoscopic ElectrodesFAS · Traditional | 12/18/1990SE |
Questions and answers
When was Hydrogel Skin Dressing cleared by the FDA?
Hydrogel Skin Dressing (K962352) received a 510(k) decision of Substantially Equivalent on August 2, 1996, 45 days after the submission was received.
What is the product code of K962352?
The FDA product code is NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic, a Class I (low risk) device regulated under 21 CFR 878.4022.