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FDA 510(k) Application Details - K143166
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K143166
Device Name
Sleeve, Limb, Compressible
Applicant
Surgical Instrument Service and Savings (dba Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 US
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Contact
Richard D. Wynkoop
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
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More FDA Info for this Product Code
Date Received
11/04/2014
Decision Date
01/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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