Comfort Cushion Dry Burn Pad III
FDA 510(k) K813419 · American Convertors Div., American Pharmaseal
510(k) numberK813419
Submission
- Device name
- Comfort Cushion Dry Burn Pad III
- Applicant
- American Convertors Div., American Pharmaseal
Mchenry, IL, US - Received
- December 7, 1981
- Decision date
- January 22, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4014
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946015 | Ivalon External SpongeNAB · Traditional | Ivalon | 02/27/1995SE |
| K940755 | Isolyer (4X4, 8PLY)NAB · Traditional | Isolyer Co. | 05/02/1994SE |
| K931610 | Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional | Omni Mfg., Inc. | 06/24/1993SE |
| K925590 | Multi-Trauma DressingNAB · Traditional | Gam Industries, Inc. | 04/08/1993SE |
| K926072 | K-Band and K-CrepeNAB · Traditional | Parema , Ltd. | 03/19/1993SE |
| K915591 | Sterile Gauze PadsNAB · Traditional | Eagle Medical, Inc. | 01/27/1993SE |
| K924650 | Gauze SpongesNAB · Traditional | Dav-Mar Medical Products, Inc. | 01/11/1993SE |
| K923602 | Absorbent Pad -- ModificationNAB · Traditional | Winfield Laboratories, Inc. | 12/07/1992SE |
| K923115 | ClinisorbNAB · Traditional | Hermitage Hospital Products, Inc. | 11/23/1992SE |
| K923378 | Usp Type Vii Gauze SpongesNAB · Traditional | E.W.A., Ltd. | 10/06/1992SE |
More from E.W.A., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K840957 | Antimicrobial Incise DrapeKKX · Traditional | 06/07/1984SE |
| K832137 | Convertors Flash Sterilizing TrayFSM · Traditional | 08/12/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | 05/18/1983SE |
| K820994 | Absorb Furn SheetFPY · Traditional | 05/13/1982SE |
| K813296 | Convertors Sterile Disp. Lap Sponge IIEFQ · Traditional | 12/29/1981SE |
| K813078 | Contura Dispos. Surg. Face MaskFXX · Traditional | 12/18/1981SE |
| K812554 | Tomac Sterile Disp. Lap SpongeGDY · Traditional | 09/24/1981SE |
| K802919 | Iso-Bac Instrument WrapFRG · Traditional | 02/02/1981SE |
| K802998 | Patient Care Disposable Infant ShirtsKME · Traditional | 12/22/1980SE |
| K802359 | Disp. Fenestrated Surg. Drape SheetsKKX · Traditional | 10/31/1980SE |
Questions and answers
When was Comfort Cushion Dry Burn Pad III cleared by the FDA?
Comfort Cushion Dry Burn Pad III (K813419) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 46 days after the submission was received.
What is the product code of K813419?
The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.