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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 K043155
Device Name STARION UNIVERSAL POWER SUPPLY (UPS)
Applicant
STARION INSTRUMENTS
20665 4TH ST.
SARATOGA,  CA  95070
Applicant Contact BRIAN GRIGSBY
Correspondent
STARION INSTRUMENTS
20665 4TH ST.
SARATOGA,  CA  95070
Correspondent Contact BRIAN GRIGSBY
Regulation Number886.4115
Classification Product Code
HQO  
Date Received11/15/2004
Decision Date 12/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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