The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Laser Photocoagulator 1520-a & K.
Device ID | K833533 |
510k Number | K833533 |
Device Name: | LASER PHOTOCOAGULATOR 1520-A & K |
Classification | Laser, Ophthalmic |
Applicant | BRITT CORP., INC. 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 | 1983-10-11 |
Decision Date | 1984-01-30 |