The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Samplette(r) Collection Tube.
| Device ID | K944083 |
| 510k Number | K944083 |
| Device Name: | MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | K. Michael Kroehnke |
| Correspondent | K. Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1995-05-26 |