FDA 510(k) Application Details - K012219

Device Classification Name Clip, Scalp

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510(K) Number K012219
Device Name Clip, Scalp
Applicant AESCULAP, INC.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact LISA M MILLINGTON
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Regulation Number 882.4150

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Classification Product Code HBO
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Date Received 07/16/2001
Decision Date 07/31/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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