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FDA 510(k) Application Details - K160704
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K160704
Device Name
Recorder, Magnetic Tape, Medical
Applicant
DMS-SERVICE LLC
11845 W. OLYMPIC BLVD STE 880W
LOS ANGELES, CA 90064 US
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Contact
LYNDA COLE
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Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
03/14/2016
Decision Date
07/15/2016
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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