The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Lyofoam Wound Dressings.
| Device ID | K860085 |
| 510k Number | K860085 |
| Device Name: | LYOFOAM WOUND DRESSINGS |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-09 |
| Decision Date | 1986-06-27 |