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510(k) K122483

PEARL DIABETES MANAGEMENT SYSTEM by Asante Solutions, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2013
Date Received
August 14, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

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