FDA 510(k) Application Details - K971565

Device Classification Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

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510(K) Number K971565
Device Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant EVEREST MEDICAL CORP.
13755 FIRST AVENUE, NORTH,
SUITE 500
MINNEAPOLIS, MN 55441-5444 US
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Contact DAVID J PARINS
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Regulation Number 884.4150

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Classification Product Code HIN
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Date Received 04/29/1997
Decision Date 03/12/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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