The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Trace Element Blood Collection Tube.
| Device ID | K883320 |
| 510k Number | K883320 |
| Device Name: | MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MO 63102 -1791 |
| Contact | Cynthia Pestka |
| Correspondent | Cynthia Pestka SHERWOOD MEDICAL CO. 1831 OLIVE ST. St. Louis, MO 63102 -1791 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-05 |
| Decision Date | 1988-09-27 |