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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K823222
Device Name INTRAOCULAR LENS GUIDE
Applicant
American Medical Optics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Medical Optics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4300
Classification Product Code
KYB  
Date Received10/29/1982
Decision Date 12/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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