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510(k) K981037

CLEAR (TM) SPECIAL NIT COMB by Care Technologies, Inc. — Product Code LJL

K981037 is an FDA 510(k) premarket notification submitted by Care Technologies, Inc. for the device "CLEAR (TM) SPECIAL NIT COMB". The FDA issued a decision of Substantially Equivalent on May 22, 1998. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Care Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1998
Date Received
March 19, 1998
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 by Care Technologies, Inc.

  • K981147 — CLEAR (TM) LICE EGG REMOVER SYSTEM (June 9, 1998)

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)
  • 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)
  • K930859 — ROBI COMBI (February 28, 1994)
  • K822574 — INNOMED PD-1 KIT (October 13, 1982)
  • K822421 — INNOCOMB LICE COMB (October 13, 1982)

FDA data resources