The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Provocative Sensitivity Balloon.
| Device ID | K901125 |
| 510k Number | K901125 |
| Device Name: | PROVOCATIVE SENSITIVITY BALLOON |
| Classification | Monitor, Esophageal Motility, And Tube |
| 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 | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1991-01-25 |