FDA 510(k) Application Details - K970050

Device Classification Name Clip, Aneurysm

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510(K) Number K970050
Device Name Clip, Aneurysm
Applicant AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO, CA 94080 US
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Contact VICTORIA MMACKINNON
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Regulation Number 882.5200

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Classification Product Code HCH
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Date Received 01/06/1997
Decision Date 11/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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