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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 K960414
Device Name SYNERGIST POWER PACK
Applicant
Chiron Vision Corp.
555 W. Arrow Hwy.
Claremont,  CA  91711
Applicant Contact JUDY F GORDON
Correspondent
Chiron Vision Corp.
555 W. Arrow Hwy.
Claremont,  CA  91711
Correspondent Contact JUDY F GORDON
Regulation Number886.4670
Classification Product Code
HQC  
Date Received01/29/1996
Decision Date 04/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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