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510(k) K151525

Amia Automated PD System with Sharesource by Deka Research and Development — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2015
Date Received
June 8, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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