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 |