K882335 is an FDA 510(k) clearance for the DISPOSABLE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 16, 1988, 10 days after receiving the submission on June 6, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K882335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1988 |
| Decision Date | June 16, 1988 |
| Days to Decision | 10 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 |