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FDA 510(k) Application Details - K990027
Device Classification Name
Recorder, Magnetic Tape, Medical
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510(K) Number
K990027
Device Name
Recorder, Magnetic Tape, Medical
Applicant
DEL MAR AVIONICS
1621 ALTON PKWY.
IRVINE, CA 92606-4801 US
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Contact
RAPHAEL HENKIN
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
01/05/1999
Decision Date
02/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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