The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Balloon Inflation Device.
| Device ID | K936168 |
| 510k Number | K936168 |
| Device Name: | WILSON-COOK BALLOON INFLATION DEVICE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Contact | Paula A Joyce |
| Correspondent | Paula A Joyce WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. Winston-salem, NC 27105 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-03-28 |