The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Prep-site Protective Dressing Wipe.
| Device ID | K811625 |
| 510k Number | K811625 |
| Device Name: | PREP-SITE PROTECTIVE DRESSING WIPE |
| Classification | Bandage, Liquid |
| Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-09 |
| Decision Date | 1981-07-10 |