FDA 510(k) Application Details - K012979

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K012979
Device Name Sleeve, Limb, Compressible
Applicant MEDICAL DEVICE SERVICES, INC.
144 WEST BRIGHAM RD. BLDG. E
ST. GEORGE, UT 84790 US
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Contact RON EAMES
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 09/05/2001
Decision Date 05/08/2002
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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