The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Piston Syringes; 3,6,12,20,35 And 60cc Sizes.
| Device ID | K945715 |
| 510k Number | K945715 |
| Device Name: | MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES |
| Classification | Syringe, Piston |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | K M Kroehnke |
| Correspondent | K M Kroehnke 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 | 1994-11-21 |
| Decision Date | 1995-03-01 |