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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K061032
Device Name DEPOTONE
Applicant
IMPRINT PHARMACEUTICALS LIMITED
53 LANGTON ROAD
EAST MOLESEY, SURREY,  GB KT8 2HX
Applicant Contact MERVYN LITTLE
Correspondent
IMPRINT PHARMACEUTICALS LIMITED
53 LANGTON ROAD
EAST MOLESEY, SURREY,  GB KT8 2HX
Correspondent Contact MERVYN LITTLE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/14/2006
Decision Date 06/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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