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510(k) K161606

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH by Terumo Europe N.V. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2017
Date Received
June 10, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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