FDA 510(k) Application Details - K172030

Device Classification Name Sleeve, Limb, Compressible

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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
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Contact Julian Chu
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Regulation Number 870.5800

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Classification Product Code JOW
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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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