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510(k) K160805

NIO-P by Waismed, Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2016
Date Received
March 23, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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  • K022415 — BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST (October 11, 2002)
  • K981853 — BONE INJECTION GUN (B.I.G.) DEVICE (November 17, 1998)

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