FDA 510(k) Application Details - K082771

Device Classification Name Stethoscope, Electronic

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510(K) Number K082771
Device Name Stethoscope, Electronic
Applicant PROTRON TECHNOLOGIES, LLC
141 OAKDENE AVE.
LEONIA, NJ 07605 US
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Contact LEON M DONDYSH
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 09/22/2008
Decision Date 02/27/2009
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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