FDA 510(k) Application Details - K122474

Device Classification Name Pump, Breast, Powered

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510(K) Number K122474
Device Name Pump, Breast, Powered
Applicant LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN
13417 QUIVAS ST
WESTMINSTER, CO 80234 US
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Contact Calley Herzog
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 08/14/2012
Decision Date 12/28/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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