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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K844150
Device Name MEDICAL OPTICS PHACOEMULSIFICATION KIT
Applicant
AMERICAN MEDICAL OPTICS
1402 EAST ALTON AVE.
IRVINE,  CA  92714
Applicant Contact PAUL S KRAMSKY
Correspondent
AMERICAN MEDICAL OPTICS
1402 EAST ALTON AVE.
IRVINE,  CA  92714
Correspondent Contact PAUL S KRAMSKY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received10/24/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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