K771359 is an FDA 510(k) clearance for the ALLERGIST PACK SYRINGES. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 28 days after receiving the submission on July 25, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K771359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1977 |
| Decision Date | August 22, 1977 |
| Days to Decision | 28 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 |