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510(k) K822574

Device
INNOMED PD-1 KIT
Applicant
INNOMED CORP.
510(k) number
K822574
Product code
LJL  
Decision
Substantially Equivalent (SESE)
Decision date
1982-10-13
Date received
1982-08-24
Regulation
880.5960
Classification name
Detectors And Removers, Lice, (including Combs)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
2629 Durant Oaks Dr. Valrico FL US 33594 33594

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151562Resultz Lice & Egg Removal KitPiedmont Pharmaceuticals, LLC2017-05-08
K163401Nix Ultra Lice Treatment KitMedtech Products, Inc.2017-03-21
K093144LOUSEBUSTERLarada Sciences2009-12-16
K083206LOUSEBUSTERLarada Sciences2009-03-10
K991958KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KITKiel Laboratories, Inc.1999-08-13
K981147CLEAR (TM) LICE EGG REMOVER SYSTEMCare Technologies, Inc.1998-06-09
K981250LICEMEISTER COMBNational Pediculosis Assoc.1998-05-28
K981037CLEAR (TM) SPECIAL NIT COMBCare Technologies, Inc.1998-05-22
K930859ROBI COMBIEpilady 2000, LLC1994-02-28
K822421INNOCOMB LICE COMBInnovative Products, Inc.1982-10-13

Legacy Summary#

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FDA Review#

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