The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Zimmon Papillotome.
| Device ID | K901443 |
| 510k Number | K901443 |
| Device Name: | ZIMMON PAPILLOTOME |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | Richard F Marshall |
| Correspondent | Richard F Marshall WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. 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 | 1990-03-27 |
| Decision Date | 1990-06-18 |