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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 K000893
Device Name AC POWERED THERMAL CAUTERY UNIT
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 Received03/20/2000
Decision Date 06/14/2000
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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