FDA 510(k) Application Details - K070339

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K070339
Device Name Thermometer, Electronic, Clinical
Applicant CINCINNATI SUB-ZERO PRODUCTS, INC
1201 MOSTELLAR ROAD
CINCINNATI, OH 45241 US
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Contact DAN WITTMER
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/05/2007
Decision Date 09/26/2007
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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