The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Sterile 6cc Syringe W/ & Wo/ Needles.
| Device ID | K852588 |
| 510k Number | K852588 |
| Device Name: | MONOJECT STERILE 6CC SYRINGE 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 | 1985-06-18 |
| Decision Date | 1985-07-23 |