FDA 510(k) Application Details - K090308

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K090308
Device Name Sleeve, Limb, Compressible
Applicant STORTFORD MEDICAL LLC
295 PRINCETON HIGHTSTOWN ROAD
UNIT 321
WEST WINDSOR, NJ 08550 US
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Contact CHRIS DAUGHTERY
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 02/06/2009
Decision Date 05/01/2009
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



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