FDA 510(k) Application Details - K010425

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

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510(K) Number K010425
Device Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant HDC CORP.
2109 O'TOOLE AVE.
SAN JOSE, CA 95131 US
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Contact EARL SMART
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Regulation Number 884.4160

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Classification Product Code KNF
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Date Received 02/13/2001
Decision Date 03/15/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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