The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Corvac Plastic Blood Collection Tube.
Device ID | K944814 |
510k Number | K944814 |
Device Name: | CORVAC PLASTIC BLOOD COLLECTION TUBE |
Classification | Tubes, Vacuum Sample, With Anticoagulant |
Applicant | SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
Contact | K M Kroehnke |
Correspondent | K M Kroehnke SHERWOOD MEDICAL CO. 1831 OLIVE ST. St.louis, MO 63103 |
Product Code | GIM |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-29 |
Decision Date | 1994-12-19 |