The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Sponge And Gauze Forcep Part #s-417-9.
Device ID | K760703 |
510k Number | K760703 |
Device Name: | SPONGE AND GAUZE FORCEP PART #S-417-9 |
Classification | Forceps, General & Plastic Surgery |
Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-23 |
Decision Date | 1976-10-21 |