The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Dravon T Clamp.
Device ID | K831842 |
510k Number | K831842 |
Device Name: | DRAVON T CLAMP |
Classification | Instrument, Surgical, Disposable |
Applicant | DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-08 |
Decision Date | 1983-09-26 |