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510(k) K143438

Flowtron ACS900 by Getinge (Suzhou) Co., Ltd. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2015
Date Received
December 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

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