The following data is part of a premarket notification filed by Mill-rose Laboratory with the FDA for Biopsy Forceps W/oval Cups.
Device ID | K820972 |
510k Number | K820972 |
Device Name: | BIOPSY FORCEPS W/OVAL CUPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | MILL-ROSE LABORATORY 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 | 1982-04-06 |
Decision Date | 1982-04-26 |