The following data is part of a premarket notification filed by Medcare Products with the FDA for Tissue Forceps.
Device ID | K822591 |
510k Number | K822591 |
Device Name: | TISSUE FORCEPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | MEDCARE PRODUCTS 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 | 1982-09-08 |
Decision Date | 1982-10-13 |