FDA 510(k) Application Details - K971621

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

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510(K) Number K971621
Device Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant AARON MEDICAL INDUSTRIES
7100 30TH AVE. NORTH
ST. PETERSBURG, FL 33710-2902 US
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Contact J. ROBERT SARON
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Regulation Number 884.4160

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Classification Product Code KNF
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Date Received 05/01/1997
Decision Date 06/20/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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