FDA 510(k) Application Details - K010752

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

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510(K) Number K010752
Device Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact LESLIE YOUNG
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Regulation Number 884.4160

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Classification Product Code KNF
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Date Received 03/13/2001
Decision Date 06/11/2001
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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