FDA 510(k) Application Details - K971026

Device Classification Name Device, Counter-Pulsating, External

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510(K) Number K971026
Device Name Device, Counter-Pulsating, External
Applicant CIRCULATOR BOOT CORP.
150 MILL CREEK RD.
ARDMORE, PA 19003 US
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Contact RICHARD S DILLON
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Regulation Number 870.5225

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Classification Product Code DRN
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Date Received 03/20/1997
Decision Date 08/14/1997
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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