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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 K931354
Device Name P4000 PHACOEMULSIFIER
Applicant
AMERICAN OPTICAL CORP.
19 HAMMOND
SUITE 505
IRVINE,  CA  92718
Applicant Contact 17 HAMMOND
Correspondent
AMERICAN OPTICAL CORP.
19 HAMMOND
SUITE 505
IRVINE,  CA  92718
Correspondent Contact 17 HAMMOND
Regulation Number886.4670
Classification Product Code
HQC  
Date Received03/17/1993
Decision Date 02/22/1994
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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