Blisterfilm Transparent Dressing
FDA 510(k) K851383 · Chesebrough-Pond'S U.S.A. Co.
510(k) numberK851383
Submission
- Device name
- Blisterfilm Transparent Dressing
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
Trumbull, CT, US - Received
- April 8, 1985
- Decision date
- July 5, 1985
- 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
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|---|---|---|---|
| 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 |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K863866 | Respiradyne Ii(Tm)BZK · Traditional | 01/28/1987SE |
| K862803 | Chesebrough Pond's Hydrocolloid DressingFRO · Traditional | 11/14/1986SN |
| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | 07/05/1985SN |
| K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional | 06/12/1985SE |
| K843567 | Kangaroo Nasogastric Feeding TubeKNT · Traditional | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | 01/15/1985SE |
| K844186 | Continent Stoma System & AccessoriesKBG · Traditional | 01/15/1985SE |
| K844789 | Kangaroo Access II Enteral Feeding ContainerKNT · Traditional | 01/02/1985SE |
| K843128 | Female Urinary Incontinence SysKNX · Traditional | 01/02/1985SE |
| K843140 | Isolate Adhesive Bandage for Dry WoundNAD · Traditional | 11/08/1984SE |
Questions and answers
When was Blisterfilm Transparent Dressing cleared by the FDA?
Blisterfilm Transparent Dressing (K851383) received a 510(k) decision of Substantially Equivalent for Some Indications on July 5, 1985, 88 days after the submission was received.
What is the product code of K851383?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.