The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Surgi-scrub V.
| Device ID | K822865 |
| 510k Number | K822865 |
| Device Name: | SURGI-SCRUB V |
| Classification | Brush, Scrub, Operating-room |
| Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1982-10-18 |