The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Lamp Delivery Sys.-photocoagulation.
Device ID | K772213 |
510k Number | K772213 |
Device Name: | LAMP DELIVERY SYS.-PHOTOCOAGULATION |
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 | 1977-12-02 |
Decision Date | 1977-12-13 |