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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K103200
Device Name PROPEP DELIVERY DEVICE
Applicant
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Applicant Contact JAMES M MEWBORNE
Correspondent
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Correspondent Contact JAMES M MEWBORNE
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MDM  
Date Received11/01/2010
Decision Date 04/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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