Frastec Conformant Dressing, Various Sizes
FDA 510(k) K885325 · Frastec Wound Care Products, Inc.
510(k) numberK885325
Submission
- Device name
- Frastec Conformant Dressing, Various Sizes
- Applicant
- Frastec Wound Care Products, Inc.
Bronx, NY, US - Received
- December 28, 1988
- Decision date
- April 17, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
Questions and answers
When was Frastec Conformant Dressing, Various Sizes cleared by the FDA?
Frastec Conformant Dressing, Various Sizes (K885325) received a 510(k) decision of Substantially Equivalent for Some Indications on April 17, 1989, 110 days after the submission was received.
What is the product code of K885325?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.