The following data is part of a premarket notification filed by Acme United Corp. with the FDA for Shear, Plastic Handle Utility S-475-7.
Device ID | K770481 |
510k Number | K770481 |
Device Name: | SHEAR, PLASTIC HANDLE UTILITY S-475-7 |
Classification | Scissors, Medical, Disposable |
Applicant | ACME UNITED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOK |
CFR Regulation Number | 880.6820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-03-11 |
Decision Date | 1977-04-29 |