FDA 510(k) Application Details - K994019

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

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510(K) Number K994019
Device Name Unit, Cautery, Thermal, Battery-Powered
Applicant STARION INSTRUMENTS
20665 4TH ST.
SARATOGA, CA 95070 US
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Contact BRIAN GRIGSBY
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Regulation Number 886.4115

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Classification Product Code HQP
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Date Received 11/26/1999
Decision Date 01/20/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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