The following data is part of a premarket notification filed by Carson Laserworks with the FDA for Jr -- Ophthalmic Argon Laser.
Device ID | K932296 |
510k Number | K932296 |
Device Name: | JR -- OPHTHALMIC ARGON LASER |
Classification | Laser, Ophthalmic |
Applicant | CARSON LASERWORKS P.O. BOX 406 Winchester, IN 47394 |
Contact | Richard Swanson |
Correspondent | Richard Swanson CARSON LASERWORKS P.O. BOX 406 Winchester, IN 47394 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-11 |
Decision Date | 1993-11-12 |