FDA 510(k) Application Details - K980631

Device Classification Name Clamp, Vascular

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510(K) Number K980631
Device Name Clamp, Vascular
Applicant EMBOL-X, INC.
645 CLYDE AVE.
MOUNTAIN VIEW, CA 94043 US
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Contact JEAN CHANG
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 02/18/1998
Decision Date 02/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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