The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Dispos. & Sponge Forceps Pean Artery.
Device ID | K843074 |
510k Number | K843074 |
Device Name: | DISPOS. & SPONGE FORCEPS PEAN ARTERY |
Classification | Forceps, General & Plastic Surgery |
Applicant | GREENE INTERNATIONAL 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 | 1984-08-06 |
Decision Date | 1984-08-17 |