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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K070871
Device Name STARION UNIVERSAL POWER SUPPLY
Applicant
STARION INSTRUMENTS
775 PALOMAR AVENUE
SUNNYVALE,  CA  94085
Applicant Contact BRIAN GRIGSBY
Correspondent
STARION INSTRUMENTS
775 PALOMAR AVENUE
SUNNYVALE,  CA  94085
Correspondent Contact BRIAN GRIGSBY
Regulation Number886.4115
Classification Product Code
HQO  
Date Received03/29/2007
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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