FDA 510(k) Application Details - K080206

Device Classification Name Clamp, Vascular

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510(K) Number K080206
Device Name Clamp, Vascular
Applicant RADI MEDICAL SYSTEMS AB
PALMBLADSGATAN 10
UPPSALA S-754 50 SE
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Contact HELENE EKSTRAND
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 01/28/2008
Decision Date 02/26/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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