The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sterile 12cc Syringes, W/wo Needles.
| Device ID | K851089 |
| 510k Number | K851089 |
| Device Name: | MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES |
| Classification | Syringe, Piston |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-04-12 |