FDA 510(k) Application Details - K003608

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K003608
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN, PA 18109 US
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Contact LISA M MILLINGTON
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 11/22/2000
Decision Date 02/20/2001
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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