The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Endoscopic Clipping Device.
Device ID | K023903 |
510k Number | K023903 |
Device Name: | WILSON-COOK ENDOSCOPIC CLIPPING DEVICE |
Classification | Hemostatic Metal Clip For The Gi Tract |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Contact | Margaret Posner |
Correspondent | Margaret Posner WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Product Code | PKL |
CFR Regulation Number | 876.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-22 |
Decision Date | 2003-02-20 |
Summary: | summary |