FDA 510(k) Application Details - K040065

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K040065
Device Name Sleeve, Limb, Compressible
Applicant JACK SPEER AND ASSOC., INC.
1800 EAST 900 SOUTH
SALT LAKE CITY, UT 84108 US
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Contact JACK SPEER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 01/13/2004
Decision Date 03/29/2004
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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