The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for J-vac Vacuum Tube.
Device ID | K771874 |
510k Number | K771874 |
Device Name: | J-VAC VACUUM TUBE |
Classification | Tubes, Vacuum Sample, With Anticoagulant |
Applicant | JELCO LABORATORIES 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 | 1977-10-03 |
Decision Date | 1977-12-02 |