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FDA 510(k) Application Details - K172030
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K172030
Device Name
Sleeve, Limb, Compressible
Applicant
Devon Medical Products (Jiangsu) Ltd.
East Half of 1-2f, Appt D2, 1, Qingfeng Road.
Nantong 226017 CN
Other 510(k) Applications for this Company
Contact
Julian Chu
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
07/05/2017
Decision Date
11/27/2017
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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