Aquaflo Hydrogel Wound Dressing & Packer
FDA 510(k) K952945 · Sherwood Medical Co.
510(k) numberK952945
Submission
- Device name
- Aquaflo Hydrogel Wound Dressing & Packer
- Applicant
- Sherwood Medical Co.
St. Louis, MO, US - Received
- June 26, 1995
- Decision date
- August 23, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
| K962352 | Hydrogel Skin DressingNAE · Traditional | North American Sterilization & Packaging Co. | 08/02/1996SE |
| 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 |
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| K960677 | Kangaroo Jejunal Feeding SystemKNT · Traditional | 05/13/1996SE |
| K960632 | Kangaroo Feeding Tube Placment StyletKNT · Traditional | 05/09/1996SE |
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| K954429 | Kangaroo Entristar Skin-Level Gastrostomy KitKNT · Traditional | 03/08/1996SESK |
| K954525 | Sensi-Touch Epidural Anesthesia FilterBXN · Traditional | 01/19/1996SE |
| K950201 | Argyle(R) Hydrophilic Coated Thoracic CatheterJOL · Traditional | 12/15/1995SE |
Questions and answers
When was Aquaflo Hydrogel Wound Dressing & Packer cleared by the FDA?
Aquaflo Hydrogel Wound Dressing & Packer (K952945) received a 510(k) decision of Substantially Equivalent for Some Indications on August 23, 1995, 58 days after the submission was received.
What is the product code of K952945?
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.