The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Usw Needleknife Papillotome.
| Device ID | K040981 |
| 510k Number | K040981 |
| Device Name: | USW NEEDLEKNIFE 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 | Marge Walls-walker |
| Correspondent | Marge Walls-walker 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-15 |
| Decision Date | 2004-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002315396 | K040981 | 000 |