K851903 is an FDA 510(k) clearance for the ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Astra Pharmaceutical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 2, 1985, 63 days after receiving the submission on April 30, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K851903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1985 |
| Decision Date | July 02, 1985 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |