The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook 10 Shot Multi-band Ligator.
Device ID | K974018 |
510k Number | K974018 |
Device Name: | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR |
Classification | Ligator, Hemorrhoidal |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Contact | Paula Joyce |
Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
Product Code | FHN |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-22 |
Decision Date | 1998-01-20 |
Summary: | summary |