FDA 510(k) Application Details - K952659

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K952659
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant TRONOMED, INC.
32921 CALLE PERFECTO
SAN JUAN CAPISTRANO, CA 92675 US
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Contact JAMES M ARGANDA
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 06/12/1995
Decision Date 01/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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