FDA 510(k) Application Details - K062364

Device Classification Name Stethoscope, Electronic

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510(K) Number K062364
Device Name Stethoscope, Electronic
Applicant DONGJIN MEDICAL CO., LTD
#1022 SICOX TOWER, 513-14
SANGDAEWON-DONG, CHUNGWON-KU
SUNGNAM-SI, KYUNGGI-DO 462-806 KR
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Contact MIN-KANG KIM
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 08/14/2006
Decision Date 12/06/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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