FDA 510(k) Application Details - K071225

Device Classification Name Clamp, Vascular

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510(K) Number K071225
Device Name Clamp, Vascular
Applicant INNOVASA, INC.
16625 REDMOND WAY
PMB M-316
REDMOND, WA 98052 US
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Contact Roberta Hines
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 05/02/2007
Decision Date 08/31/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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