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510(k) K051045

SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 by Spectrx, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2005
Date Received
April 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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