The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Photocoagulator Laser.
Device ID | K780345 |
510k Number | K780345 |
Device Name: | PHOTOCOAGULATOR LASER |
Classification | Photocoagulator And Accessories |
Applicant | CAVITRON CORP. 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 | 1978-03-01 |
Decision Date | 1978-05-09 |