FDA 510(k) Application Details - K161209

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K161209
Device Name Sleeve, Limb, Compressible
Applicant DEVON MEDICAL PRODUCTS
1100 FIRST AVENUE
KING OF PRUSSIA, PA 19119 US
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Contact ROCCO BRAVOCO
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 04/28/2016
Decision Date 05/31/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K161209


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