FDA 510(k) Application Details - K070871

Device Classification Name Unit, Cautery, Thermal, Ac-Powered

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510(K) Number K070871
Device Name Unit, Cautery, Thermal, Ac-Powered
Applicant STARION INSTRUMENTS
775 PALOMAR AVENUE
SUNNYVALE, CA 94085 US
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Contact BRIAN GRIGSBY
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Regulation Number 886.4115

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Classification Product Code HQO
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Date Received 03/29/2007
Decision Date 04/13/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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