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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 K874747
Device Name 10CC SYRINGE CONTROL RING SET
Applicant
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Applicant Contact KURT GEORGE
Correspondent
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Correspondent Contact KURT GEORGE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/18/1987
Decision Date 02/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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