The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Modified Lyofoam Wound Dressings.
| Device ID | K895764 |
| 510k Number | K895764 |
| Device Name: | MODIFIED LYOFOAM WOUND DRESSINGS |
| Classification | Bandage, Liquid |
| Applicant | ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Contact | A. T Harrison |
| Correspondent | A. T Harrison ACME UNITED CORP. 425 POST RD. Fairfield, CT 06430 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1990-09-10 |