FDA 510(k) Application Details - K983744

Device Classification Name Clip, Vascular

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510(K) Number K983744
Device Name Clip, Vascular
Applicant APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS, CA 92653 US
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Contact HOWARD V ROWE
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Regulation Number 870.3250

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Classification Product Code DSS
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Date Received 10/23/1998
Decision Date 01/21/1999
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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