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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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More FDA Info for this Product Code
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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