The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Laser, Photocoagulation.
Device ID | K782065 |
510k Number | K782065 |
Device Name: | LASER, PHOTOCOAGULATION |
Classification | Laser, Ophthalmic |
Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-13 |
Decision Date | 1978-12-28 |