FDA 510(k) Application Details - K001025

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K001025
Device Name Recorder, Magnetic Tape, Medical
Applicant REYNOLDS MEDICAL LTD.
377 RT. 17 S.
HASBROUCK HEIGHTS, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 03/30/2000
Decision Date 04/19/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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