The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Vacuum Tubes, Pediatric Sizes (j-vac).
Device ID | K760019 |
510k Number | K760019 |
Device Name: | VACUUM TUBES, PEDIATRIC SIZES (J-VAC) |
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 | 1976-06-11 |
Decision Date | 1976-07-20 |