The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Blood Collection Tubes W/safety Stopper.
| Device ID | K940058 |
| 510k Number | K940058 |
| Device Name: | MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-05 |
| Decision Date | 1994-05-02 |