The following data is part of a premarket notification filed by American Medical Optics with the FDA for Amer. Medical Optics Argon/krypton Lase.
Device ID | K842250 |
510k Number | K842250 |
Device Name: | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE |
Classification | Laser, Ophthalmic |
Applicant | AMERICAN MEDICAL OPTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-30 |
Decision Date | 1984-08-15 |