The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Tri-tome Select Plus.
| Device ID | K033203 | 
| 510k Number | K033203 | 
| Device Name: | WILSON-COOK TRI-TOME SELECT PLUS | 
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) | 
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 | 
| Contact | Marge Walls-walker | 
| Correspondent | Marge Walls-walker 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 | 2003-10-02 | 
| Decision Date | 2003-12-19 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00827002315334 | K033203 | 000 |