FDA 510(k) Application Details - K143166

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K143166
Device Name Sleeve, Limb, Compressible
Applicant Surgical Instrument Service and Savings (dba Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 US
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Contact Richard D. Wynkoop
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 11/04/2014
Decision Date 01/16/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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