The following data is part of a premarket notification filed by Sterling Drug, Inc. with the FDA for Empty Sterile Carpuject.
| Device ID | K820164 |
| 510k Number | K820164 |
| Device Name: | EMPTY STERILE CARPUJECT |
| Classification | Syringe, Piston |
| Applicant | STERLING DRUG, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-20 |
| Decision Date | 1982-02-24 |