The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Rotatable Polypectomy Snare Pos-1.
Device ID | K851958 |
510k Number | K851958 |
Device Name: | ROTATABLE POLYPECTOMY SNARE POS-1 |
Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Contact | Jon Wilson |
Correspondent | Jon Wilson WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
Product Code | KNS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-03 |
Decision Date | 1985-07-25 |