The following data is part of a premarket notification filed by Acme United Corp. with the FDA for One Time Compound Benzoin Tincture-.
| Device ID | K833120 |
| 510k Number | K833120 |
| Device Name: | ONE TIME COMPOUND BENZOIN TINCTURE- |
| Classification | Tape And Bandage, Adhesive |
| Applicant | ACME UNITED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-13 |
| Decision Date | 1983-12-29 |