K961693 is an FDA 510(k) clearance for the DALE GASTROSTOMY TUBE HOLDER. This device is classified as a Gastrointestional Tube Holder (Class II - Special Controls, product code PLI).
Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on July 30, 1996, 90 days after receiving the submission on May 1, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. Intended To Support, Secure, And Hold Gastrointestinal Tubes.
| 510(k) Number | K961693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1996 |
| Decision Date | July 30, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | PLI — Gastrointestional Tube Holder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | Intended To Support, Secure, And Hold Gastrointestinal Tubes |