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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K060772
Device Name MANUEL SAFTEY SYRINGE PARTS 1 & 2
Applicant
Medsafe Asa
Forskningsvein 2a N-0373
Oslo,  NO
Applicant Contact NILS GUNNARSSON
Correspondent
Medsafe Asa
Forskningsvein 2a N-0373
Oslo,  NO
Correspondent Contact NILS GUNNARSSON
Regulation Number880.5860
Classification Product Code
MEG  
Date Received03/22/2006
Decision Date 10/16/2006
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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