The following data is part of a premarket notification filed by Top Surgical Manufacturers Co. with the FDA for Top Hypodermic Syringe Luer Lock.
| Device ID | K843415 |
| 510k Number | K843415 |
| Device Name: | TOP HYPODERMIC SYRINGE LUER LOCK |
| Classification | Syringe, Piston |
| Applicant | TOP SURGICAL MANUFACTURERS CO. 7660 WEST FREMONT AVE. Littleton, CO 80123 |
| Contact | Tadayoshi Imamura |
| Correspondent | Tadayoshi Imamura TOP SURGICAL MANUFACTURERS CO. 7660 WEST FREMONT AVE. Littleton, CO 80123 |
| 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 | 1984-12-07 |