The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Pharmacy Tray.
Device ID | K860688 |
510k Number | K860688 |
Device Name: | MONOJECT PHARMACY TRAY |
Classification | Syringe, Piston |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Fucile, Jr. |
Correspondent | Fucile, Jr. 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 | 1986-02-25 |
Decision Date | 1987-08-06 |