The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Catheter Tubing Modification.
Device ID | K790107 |
510k Number | K790107 |
Device Name: | CATHETER TUBING MODIFICATION |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-16 |
Decision Date | 1979-02-01 |