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510(k) K211968

NIO+ Adult by Waismed, Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2021
Date Received
June 24, 2021
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

Other clearances by Waismed, Ltd.

  • K190538 — NIO-I (October 7, 2019)
  • K160805 — NIO-P (June 23, 2016)
  • K142086 — NIO -INTRAOSSEOUS DEVICE (August 28, 2014)
  • K062940 — BONE INJECTION GUN (B.I.G.) (December 22, 2006)
  • 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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