The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Brandt Esophageal Cytology Balloon.
| Device ID | K911588 |
| 510k Number | K911588 |
| Device Name: | BRANDT ESOPHAGEAL CYTOLOGY BALLOON |
| Classification | Esophagoscope (flexible Or Rigid) |
| 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 | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1992-11-18 |