FDA 510(k) Application Details - K080551

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K080551
Device Name Sleeve, Limb, Compressible
Applicant UNIVERSITY OF UTAH HOSPITALS AND CLINICS
50 NORTH MEDICAL DR.
SALT LAKE CITY, UT 84132 US
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Contact BRENT ALM
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 02/28/2008
Decision Date 05/28/2008
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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