The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Photocoagulator, Log 3 Portable Xenon.
Device ID | K760444 |
510k Number | K760444 |
Device Name: | PHOTOCOAGULATOR, LOG 3 PORTABLE XENON |
Classification | Photocoagulator And Accessories |
Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQB |
CFR Regulation Number | 886.4690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-16 |
Decision Date | 1976-08-26 |