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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 K060002
Device Name RITRACT SAFETY SYRINGE
Applicant
Ritract , Ltd.
201 Miller St.
Level 17
North Sydney, New South Wales,  AU 2060
Applicant Contact RUPERT NORTHCOTT
Correspondent
Ritract , Ltd.
201 Miller St.
Level 17
North Sydney, New South Wales,  AU 2060
Correspondent Contact RUPERT NORTHCOTT
Regulation Number880.5860
Classification Product Code
MEG  
Date Received01/03/2006
Decision Date 06/02/2006
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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