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FDA 510(k) Application Details - K981311
Device Classification Name
Sleeve, Limb, Compressible
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510(K) Number
K981311
Device Name
Sleeve, Limb, Compressible
Applicant
KCI NEW TECHNOLOGIES, INC.
8023 VANTAGE DR.
SAN ANTONIO, TX 78230-4726 US
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Contact
JUDITH HARBOUR
Other 510(k) Applications for this Contact
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
04/10/1998
Decision Date
04/23/1999
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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