The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Pattison Esophageal Dilator.
| Device ID | K971615 |
| 510k Number | K971615 |
| Device Name: | PATTISON ESOPHAGEAL DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | TRI-MED SPECIALTIES, INC. 16309 WEST 108TH CIRCLE Lenexa, KS 66219 |
| Contact | Mike Knoth |
| Correspondent | Mike Knoth TRI-MED SPECIALTIES, INC. 16309 WEST 108TH CIRCLE Lenexa, KS 66219 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-07-24 |