FDA 510(k) Application Details - K122499

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K122499
Device Name Sleeve, Limb, Compressible
Applicant DJO, LLC
1430 DECISION STREET
VISTA, CA 92081-8553 US
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Contact KEN FISHER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 08/16/2012
Decision Date 10/18/2012
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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