FDA 510(k) Application Details - K973592

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K973592
Device Name Sleeve, Limb, Compressible
Applicant A. STEIN - REGULATORY AFFAIRS CONSULTING
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact AHAVA STEIN
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 09/22/1997
Decision Date 05/20/1999
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



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