The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Cannula, Artery, Renal.
Device ID | K780079 |
510k Number | K780079 |
Device Name: | CANNULA, ARTERY, RENAL |
Classification | Cannula, Catheter |
Applicant | DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-16 |
Decision Date | 1978-02-13 |