K913784 is an FDA 510(k) clearance for the DOBBHOFF(R) SINGLE PASS PEG KIT, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on January 15, 1992, 145 days after receiving the submission on August 23, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K913784 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | August 23, 1991 |
| Decision Date | January 15, 1992 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |