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510(k) K061039

AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE by Amsino International, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2006
Date Received
April 14, 2006
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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