The following data is part of a premarket notification filed by American Silk Sutures, Inc. with the FDA for American Burn Sheet.
| Device ID | K922143 |
| 510k Number | K922143 |
| Device Name: | AMERICAN BURN SHEET |
| Classification | Bedding, Disposable, Medical |
| Applicant | AMERICAN SILK SUTURES, INC. 82 SANDERSON AVE. Lynn, MA 01902 |
| Contact | Edward M Greenspan |
| Correspondent | Edward M Greenspan AMERICAN SILK SUTURES, INC. 82 SANDERSON AVE. Lynn, MA 01902 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1992-08-10 |