The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Disposable Hot Biopsy Forceps.
Device ID | K923470 |
510k Number | K923470 |
Device Name: | DISPOSABLE HOT BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Electric |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Contact | Richard F Marshall |
Correspondent | Richard F Marshall WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Product Code | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-14 |
Decision Date | 1993-04-21 |