FDA 510(k) Application Details - K000098

Device Classification Name Clamp, Vascular

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510(K) Number K000098
Device Name Clamp, Vascular
Applicant NOVARE SURGICAL SYSTEMS, INC.
10231 BUBB RD.
CUPERTINO, CA 95014 US
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Contact TERRY BUELNA
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 01/13/2000
Decision Date 04/12/2000
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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