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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 K161606
Device Name Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
Applicant
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Applicant Contact M.J. AERTS
Correspondent
Terumo Europe N.V.
Interleuvenlaan 40
Leuven,  BE 3001
Correspondent Contact M.J. AERTS
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received06/10/2016
Decision Date 02/10/2017
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 Yes
Predetermined Change
Control Plan Authorized		 No
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