American Burn Sheet
FDA 510(k) K922143 · American Silk Sutures, Inc.
510(k) numberK922143
Submission
- Device name
- American Burn Sheet
- Applicant
- American Silk Sutures, Inc.
Lynn, MA, US - Received
- May 6, 1992
- Decision date
- August 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KME – Bedding, Disposable, Medical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6060
- Specialty
- General Hospital
Other 510(k)s with product code KME
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042145 | Ready-Heat BlanketKME · Traditional | Techtrade, LLC | 09/17/2004SE |
| K944953 | Orex Medical BeddingKME · Traditional | Thantex Specialties, Inc. | 12/02/1994SE |
| K933636 | Dispose-A-SheetKME · Traditional | Belmac Healthcare Corp. | 01/26/1994SE |
| K932539 | Doctor Down --Rescue WrapKME · Traditional | Three Dog Down | 11/02/1993SE |
| K915303 | Foil Baby BuntingKME · Traditional | Gam Industries, Inc. | 02/20/1992SE |
| K912257 | Chem-Sleeve BKME · Traditional | Haz-Med, Inc. | 12/31/1991SE |
| K911953 | Medi Guard Sheets/UnderlaysKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911952 | Medi Guard UnderpadKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911948 | Medi Guard PillowcaseKME · Traditional | Sancella, Inc. | 05/28/1991SE |
| K911950 | Medi Guard DrapesKME · Traditional | Sancella, Inc. | 05/21/1991SE |
More from Sancella, Inc.
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| K904514 | Strung Telfa Non-Adherent SpongeHBA · Traditional | 03/27/1991SE |
| K902921 | Rayon Neurological SpongeHBA · Traditional | 09/18/1990SE |
| K872810 | Strung Dental RollsEFN · Traditional | 12/04/1987SE |
| K872951 | American Brain Retractor CoverGET · Traditional | 09/16/1987SE |
| K872905 | American Nasal SpongeEPP · Traditional | 09/04/1987SE |
| K872906 | Suction Tube Tip Fits Over Bussie Frazier TubeGEA · Traditional | 08/11/1987SE |
| K872809 | Gauze Cherry SpongeGDY · Traditional | 08/04/1987SE |
| K872808 | Chevron Tape Dissector, 9/16 X 1/4, 9/16 X 1/8EFQ · Traditional | 08/04/1987SE |
| K872807 | Non-Woven Tracheotomy SpongeGDY · Traditional | 08/04/1987SE |
| K872806 | Stick Sponge, Strung Tonsil Sponge Double StrungEFQ · Traditional | 08/04/1987SE |
Questions and answers
When was American Burn Sheet cleared by the FDA?
American Burn Sheet (K922143) received a 510(k) decision of Substantially Equivalent on August 10, 1992, 96 days after the submission was received.
What is the product code of K922143?
The FDA product code is KME – Bedding, Disposable, Medical, a Class I (low risk) device regulated under 21 CFR 880.6060.