FDA 510(k) Application Details - K241746

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K241746
Device Name Sleeve, Limb, Compressible
Applicant United Medical Resources LLC
270 W 500 N
North Salt Lake, UT 84054 US
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Contact Chase Williams
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 06/18/2024
Decision Date 10/04/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241746


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