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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K062257
Device Name STARION INSTRUMENTS THERMAL LITIGATING SHEARS
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 Number878.4400
Classification Product Code
GEI  
Date Received08/04/2006
Decision Date 10/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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