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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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More FDA Info for this Product Code
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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