The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Safety Syringe, 1 Cc, 3cc And 12 Cc Sizes.
| Device ID | K922522 |
| 510k Number | K922522 |
| Device Name: | MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES |
| 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 | 1992-05-28 |
| Decision Date | 1992-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521015043 | K922522 | 000 |
| 10884521015012 | K922522 | 000 |
| 10884521014992 | K922522 | 000 |
| 30884521014972 | K922522 | 000 |
| 10884521014961 | K922522 | 000 |
| 30884521014958 | K922522 | 000 |
| 10884521014947 | K922522 | 000 |
| 10884521014930 | K922522 | 000 |