The following data is part of a premarket notification filed by Astra Pharmaceutical Products, Inc. with the FDA for Astra Lightweight Stainless Steel Self Aspir/syrin.
| Device ID | K851903 |
| 510k Number | K851903 |
| Device Name: | ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN |
| Classification | Syringe, Cartridge |
| Applicant | ASTRA PHARMACEUTICAL PRODUCTS, INC. 50 OTIS ST. Westborough, MA 01581 |
| Contact | Bruce R Manning |
| Correspondent | Bruce R Manning ASTRA PHARMACEUTICAL PRODUCTS, INC. 50 OTIS ST. Westborough, MA 01581 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-07-02 |