The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Samplette Amber Capillary Serum Separator.
| Device ID | K875061 |
| 510k Number | K875061 |
| Device Name: | MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Frank S Morrison |
| Correspondent | Frank S Morrison SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-01-12 |