The following data is part of a premarket notification filed by Reznik Instruments with the FDA for Forcep.
Device ID | K812205 |
510k Number | K812205 |
Device Name: | FORCEP |
Classification | Forceps, General & Plastic Surgery |
Applicant | REZNIK INSTRUMENTS 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 | 1981-08-04 |
Decision Date | 1981-10-26 |