The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Needle, Blood Collecting.
Device ID | K790079 |
510k Number | K790079 |
Device Name: | NEEDLE, BLOOD COLLECTING |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-09 |
Decision Date | 1979-02-01 |