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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K051045
Device Name SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
Applicant
Spectrx, Inc.
4955 Avalon Ridge Pkwy.
Norcross,  GA  30071
Applicant Contact WILLIAM M VONDERSMITH
Correspondent
Spectrx, Inc.
4955 Avalon Ridge Pkwy.
Norcross,  GA  30071
Correspondent Contact WILLIAM M VONDERSMITH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/25/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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