The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Blood Collection Tube, Red.
Device ID | K771055 |
510k Number | K771055 |
Device Name: | BLOOD COLLECTION TUBE, RED |
Classification | Tubes, Vacuum Sample, With Anticoagulant |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GIM |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-13 |
Decision Date | 1977-06-29 |