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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 K112475
Device Name XTRACT SYRINGE KEY SYSTEM
Applicant
Xtract Solutions
9495 SW Locust Suite E
Portland,  OR  97223
Applicant Contact KEITH LOWREY
Correspondent
Xtract Solutions
9495 SW Locust Suite E
Portland,  OR  97223
Correspondent Contact KEITH LOWREY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/29/2011
Decision Date 11/10/2011
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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