The following data is part of a premarket notification filed by Mr Associates, Inc. with the FDA for Biopsy Forceps W/needle M.r. Assoc..
Device ID | K800963 |
510k Number | K800963 |
Device Name: | BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. |
Classification | Forceps, Biopsy, Non-electric |
Applicant | MR ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FCL |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-23 |
Decision Date | 1980-05-08 |