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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 K161812
Device Name Freedom Syringe
Applicant
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Applicant Contact Doug Rowley
Correspondent
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Correspondent Contact Doug Rowley
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/01/2016
Decision Date 03/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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