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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 K961658
Device Name MEGATRON OPHTHALMIC SURGICAL SYSTEM
Applicant
INTL. OPHTHALMIC INDUSTRIES CORP.
344 ANNABELLE POINT RD.
P.O. BOX 628
CENTERVILLE,  MA  02632
Applicant Contact HILLARD W WELCH
Correspondent
INTL. OPHTHALMIC INDUSTRIES CORP.
344 ANNABELLE POINT RD.
P.O. BOX 628
CENTERVILLE,  MA  02632
Correspondent Contact HILLARD W WELCH
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received04/29/1996
Decision Date 07/23/1996
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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