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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 K894512
Device Name PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
Applicant
INTL. OPHTHALMIC INDUSTRIES CORP.
54 BAY STATE RD.
WESTON,  MA  02193
Applicant Contact HILLARD W WELCH
Correspondent
INTL. OPHTHALMIC INDUSTRIES CORP.
54 BAY STATE RD.
WESTON,  MA  02193
Correspondent Contact HILLARD W WELCH
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/19/1989
Decision Date 10/17/1989
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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