The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson Cook Multiple Band Ligator.
Device ID | K944220 |
510k Number | K944220 |
Device Name: | WILSON COOK MULTIPLE BAND LIGATOR |
Classification | Ligator, Esophageal |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Contact | Paula Joyce |
Correspondent | Paula Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Product Code | MND |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-29 |
Decision Date | 1995-01-24 |