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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cautery, Radiofrequency, Ac-Powered
510(k) Number K050308
Device Name THERMAL CAUTERY PROBE
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 Number886.4100
Classification Product Code
HQR  
Date Received02/08/2005
Decision Date 02/25/2005
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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