The following data is part of a premarket notification filed by American Medical Optics with the FDA for Intraocular Lens Guide.
Device ID | K823222 |
510k Number | K823222 |
Device Name: | INTRAOCULAR LENS GUIDE |
Classification | Lens, Guide, Intraocular |
Applicant | AMERICAN MEDICAL OPTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-29 |
Decision Date | 1982-12-28 |