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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 K902876
Device Name PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.
Applicant
Intraoptics Surgical, Inc.
15500-A Rockfield
Irvine,  CA  92718
Applicant Contact DAN BROSTOFF
Correspondent
Intraoptics Surgical, Inc.
15500-A Rockfield
Irvine,  CA  92718
Correspondent Contact DAN BROSTOFF
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/02/1990
Decision Date 09/18/1990
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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