The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Inflatable Esophageal Dilator.
| Device ID | K932015 |
| 510k Number | K932015 |
| Device Name: | TRI-MED INFLATABLE ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Contact | Larry Scott |
| Correspondent | Larry Scott TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1994-02-03 |