FDA 510(k) Application Details - K013331

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K013331
Device Name Sleeve, Limb, Compressible
Applicant MEGO AFEK
BEIT HAPA'AMON (BOX 124)
20 HATA'AS ST.
KFAR SABA 44425 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 10/05/2001
Decision Date 11/30/2001
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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