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FDA 510(k) Application Details - K122873
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K122873
Device Name
Sleeve, Limb, Compressible
Applicant
CAREMED SUPPLY, INC.
7F, NO.2, LANE 235, BAO CHIAO RD
NEW TAIPEI CITY
TAIPEI XEN DISTRICT 23145 CN
Other 510(k) Applications for this Company
Contact
MICHAEL LEE
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2012
Decision Date
01/15/2013
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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