FDA 510(k) Application Details - K111282

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K111282
Device Name Thermometer, Electronic, Clinical
Applicant STARBOARD MEDICAL, LLC
22845 SAVI RANCH PKWY
SUITE H
Yorba Linda, CA 92887 US
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Contact ANTHONY BERAN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/06/2011
Decision Date 08/11/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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