FDA 510(k) Application Details - K073028

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K073028
Device Name Sleeve, Limb, Compressible
Applicant VENOWAVE, INC.
13231 KENNEDY ROAD
STOUFFVILLE, ONTARIO L4A 7X5 CA
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Contact JOHN SARINGER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 10/26/2007
Decision Date 03/07/2008
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

FDA Source Information for K073028


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