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FDA 510(k) Application Details - K971968
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K971968
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE COURT
ALPHARETTA, GA 30202 US
Other 510(k) Applications for this Company
Contact
DON ROSVOLD
Other 510(k) Applications for this Contact
Regulation Number
870.2900
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Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/1997
Decision Date
07/23/1997
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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