K971615 is an FDA 510(k) clearance for the PATTISON ESOPHAGEAL DILATOR. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Tri-Med Specialties, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 24, 1997, 83 days after receiving the submission on May 2, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K971615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1997 |
| Decision Date | July 24, 1997 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |