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510(k) K822574

INNOMED PD-1 KIT by Innomed Corp. — Product Code LJL

K822574 is an FDA 510(k) premarket notification submitted by Innomed Corp. for the device "INNOMED PD-1 KIT". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code LJL (Detectors And Removers, Lice, (Including Combs)), a Class I device regulated under 21 CFR 880.5960. Innomed Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
August 24, 1982
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 Innomed Corp.

  • K872747 — LASER CENTERING DEVICE (September 4, 1987)
  • K827796 — INNOSCAN EXAMINATION LIGHT (August 24, 1982)

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)
  • K981037 — CLEAR (TM) SPECIAL NIT COMB (May 22, 1998)
  • K930859 — ROBI COMBI (February 28, 1994)
  • K822421 — INNOCOMB LICE COMB (October 13, 1982)

FDA data resources