FDA 510(k) Application Details - K971444

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K971444
Device Name Electrode, Electrocardiograph
Applicant 3M MEDICAL PRODUCTS GROUP
3M CENTER, BLDG. 275-3E-08
ST. PAUL, MN 55144-1000 US
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Contact LINDA JOHNSEN
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 04/21/1997
Decision Date 06/11/1997
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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