FDA 510(k) Application Details - K050097

Device Classification Name Stethoscope, Electronic

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510(K) Number K050097
Device Name Stethoscope, Electronic
Applicant TECHTRADE LLC
11900 GAINSBOROUGH ROAD
P.O.BOX 2005
POTOMAC, MD 20854-3305 US
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Contact ARTHUR M HOROWITZ
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Regulation Number 870.1875

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Classification Product Code DQD
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Date Received 01/14/2005
Decision Date 09/30/2005
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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