K964120 is an FDA 510(k) clearance for the INJECTO FLUSH, a Forceps, Biopsy, Non-electric (Class I — General Controls, product code FCL), submitted by Robert J. Jynch, Jr. (Pittsburgh, US). The FDA issued a Cleared decision on December 30, 1996, 76 days after receiving the submission on October 15, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K964120 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1996 |
| Decision Date | December 30, 1996 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCL — Forceps, Biopsy, Non-electric |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1075 |