The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Lyosheet Surgical Sheet For Burns.
| Device ID | K871740 |
| 510k Number | K871740 |
| Device Name: | LYOSHEET SURGICAL SHEET FOR BURNS |
| Classification | Sheet, Burn |
| Applicant | ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Contact | Susan L Carey |
| Correspondent | Susan L Carey ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Product Code | FPY |
| CFR Regulation Number | 880.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-05 |
| Decision Date | 1987-06-09 |