FDA 510(k) Application Details - K971504

Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording

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510(K) Number K971504
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant J-LLOYD MEDICAL, INC.
415 COMMERCE LANE, SUITE 7
WEST BERLIN, NJ 08091 US
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Contact JAMES L SKAGGS
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 04/25/1997
Decision Date 04/20/1998
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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