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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K851264
Device Name AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
Applicant
American Medical Optics
1402 E. Alton Ave.
Irvine,  CA  92714
Applicant Contact PAUL S KRAMSKY
Correspondent
American Medical Optics
1402 E. Alton Ave.
Irvine,  CA  92714
Correspondent Contact PAUL S KRAMSKY
Regulation Number886.1570
Classification Product Code
HLI  
Date Received03/28/1985
Decision Date 05/01/1985
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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