The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Tamponade Balloon Cuff.
| Device ID | K833859 |
| 510k Number | K833859 |
| Device Name: | TAMPONADE BALLOON CUFF |
| Classification | Endoscope, Ac-powered And Accessories |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-07 |
| Decision Date | 1984-01-03 |