The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Utility Scissors Disposable Items.
Device ID | K843075 |
510k Number | K843075 |
Device Name: | UTILITY SCISSORS DISPOSABLE ITEMS |
Classification | Scissors, Medical, Disposable |
Applicant | GREENE INTERNATIONAL 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 | 1984-08-06 |
Decision Date | 1984-09-05 |