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
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Regulation Number 870.5800

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Classification Product Code JOW
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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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