FDA 510(k) Application Details - K003965

Device Classification Name Cannula, Surgical, General & Plastic Surgery

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510(K) Number K003965
Device Name Cannula, Surgical, General & Plastic Surgery
Applicant AESCULAP, INC.
944 MARCON BLVD.
ALLENTOWN, PA 18109 US
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Contact LISA M MILLINGTON
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Regulation Number 878.4800

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Classification Product Code GEA
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Date Received 12/22/2000
Decision Date 03/16/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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