The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for American Dilatation System.
| Device ID | K853274 |
| 510k Number | K853274 |
| Device Name: | AMERICAN DILATATION SYSTEM |
| Classification | Dilator, Esophageal |
| Applicant | AMERICAN ENDOSCOPY, INC. 9350 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Marlin E Younker |
| Correspondent | Marlin E Younker AMERICAN ENDOSCOPY, INC. 9350 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-17 |