FDA 510(k) Application Details - K961166

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K961166
Device Name Sleeve, Limb, Compressible
Applicant HNE HEALTHCARE, INC.
227 ROUTE 33 EAST
MANALAPAN, NJ 07726 US
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Contact AUDREY WITKO
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 03/25/1996
Decision Date 10/11/1996
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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