FDA 510(k) Application Details - K954489

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K954489
Device Name Sleeve, Limb, Compressible
Applicant DELPHI CONSULTING GROUP
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact J. HARVEY KNAUSS
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 09/27/1995
Decision Date 02/22/1996
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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