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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, Battery-Powered
510(k) Number K002547
Device Name STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
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
HQP  
Subsequent Product Code
GEI  
Date Received08/17/2000
Decision Date 10/20/2000
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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