The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Lyofoam Extra 'a' Sterile Adhesive Wound Dressing.
| Device ID | K961452 |
| 510k Number | K961452 |
| Device Name: | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | ACME UNITED CORP. 75 KINGS HWY. CUT-OFF Fairfield, CT 06430 |
| Contact | Thomas E Flynn |
| Correspondent | Thomas E Flynn ACME UNITED CORP. 75 KINGS HWY. CUT-OFF Fairfield, CT 06430 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-16 |
| Decision Date | 1996-05-31 |
| Summary: | summary |