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510(k) K163401

Nix Ultra Lice Treatment Kit by Medtech Products, Inc. — Product Code LJL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2017
Date Received
December 5, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detectors And Removers, Lice, (Including Combs)
Device Class
Class I
Regulation Number
880.5960
Review Panel
HO
Submission Type

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Other clearances for product code LJL

  • K151562 — Resultz Lice & Egg Removal Kit (May 8, 2017)
  • K093144 — LOUSEBUSTER (December 16, 2009)
  • K083206 — LOUSEBUSTER (March 10, 2009)
  • K991958 — KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT (August 13, 1999)
  • K981147 — CLEAR (TM) LICE EGG REMOVER SYSTEM (June 9, 1998)
  • K981250 — LICEMEISTER COMB (May 28, 1998)
  • K981037 — CLEAR (TM) SPECIAL NIT COMB (May 22, 1998)
  • K930859 — ROBI COMBI (February 28, 1994)
  • K822421 — INNOCOMB LICE COMB (October 13, 1982)
  • K822574 — INNOMED PD-1 KIT (October 13, 1982)