FDA 510(k) Application Details - K071040

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K071040
Device Name Sleeve, Limb, Compressible
Applicant WRIGHT LINEAR PUMP, INC.
103-B INTERNATIONAL DR.
OAKDALE, PA 15071-3907 US
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Contact CAROL WRIGHT
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 04/12/2007
Decision Date 05/22/2007
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 Y
Expedited Review



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