The following data is part of a premarket notification filed by Conphar, Inc. with the FDA for Operating 5 & 1/2 Straigh Sharp/blunt.
Device ID | K821122 |
510k Number | K821122 |
Device Name: | OPERATING 5 & 1/2 STRAIGH SHARP/BLUNT |
Classification | Cutter, Surgical |
Applicant | CONPHAR, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FZT |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-20 |
Decision Date | 1982-05-07 |