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510(k) K161654

NuFACE Gel Primer by Carol Cole Company — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2016
Date Received
June 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Carol Cole Company

  • K133823 — NUFACE MINI DEVICE (April 17, 2014)
  • K131251 — TRINITY ELE (October 1, 2013)
  • K120560 — TRINITY WRINKLE REMOVER (November 6, 2012)
  • K103472 — NUFACE PLUS (November 7, 2011)
  • K072260 — NUFACE, MODEL NU-4003 (November 27, 2007)

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