The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Zimmon Esophago-gastric Balloon Tamponade Device.
| Device ID | K900623 |
| 510k Number | K900623 |
| Device Name: | ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem, NC 27105 |
| Contact | F Marshall |
| Correspondent | F Marshall WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. 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 | 1990-02-08 |
| Decision Date | 1991-10-07 |