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FDA 510(k) Application Details - K952659
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2900
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Classification Product Code
DSA
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More FDA Info for this Product Code
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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