The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Samplette Separator Tube.
| Device ID | K941291 |
| 510k Number | K941291 |
| Device Name: | MONOJECT SAMPLETTE SEPARATOR TUBE |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-10-27 |