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510(k) K142086

NIO -INTRAOSSEOUS DEVICE by Waismed, Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2014
Date Received
July 31, 2014
Clearance Type
Special
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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  • K981853 — BONE INJECTION GUN (B.I.G.) DEVICE (November 17, 1998)

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