The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Top Hypodermic Syringe Piston.
| Device ID | K843414 |
| 510k Number | K843414 |
| Device Name: | TOP HYPODERMIC SYRINGE PISTON |
| Classification | Syringe, Piston |
| Applicant | TOP SURGICAL MANUFACTURERS CO. 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 | 1984-08-31 |
| Decision Date | 1984-09-07 |