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510(k) K991958

KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT by Kiel Laboratories, Inc. — Product Code LJL

K991958 is an FDA 510(k) premarket notification submitted by Kiel Laboratories, Inc. for the device "KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1999
Date Received
June 10, 1999
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

Other clearances for product code LJL

  • K151562 — Resultz Lice & Egg Removal Kit (May 8, 2017)
  • K163401 — Nix Ultra Lice Treatment Kit (March 21, 2017)
  • K093144 — LOUSEBUSTER (December 16, 2009)
  • K083206 — LOUSEBUSTER (March 10, 2009)
  • 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)
  • K822574 — INNOMED PD-1 KIT (October 13, 1982)
  • K822421 — INNOCOMB LICE COMB (October 13, 1982)

FDA data resources