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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
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
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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