K853120 is an FDA 510(k) clearance for the ADDITIVE EXTENSION SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 5, 1985, 133 days after receiving the submission on July 25, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K853120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1985 |
| Decision Date | December 05, 1985 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |