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510(k) K832667

Device
LUCAE'S EAR & NASAL APPLICATORS
Applicant
KELLS MEDICAL, INC.
510(k) number
K832667
Product code
KCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-29
Date received
1983-08-09
Regulation
874.5220
Classification name
Applicator, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923679ENDOPATH TISSUE RETAINING COMPONENTEthicon Endo-Surgery, Inc.1992-09-09
K921053LAPAROMED LIGATING LOOPLaparomed Corp.1992-08-06
K894369APDYNE PHENOL APPLICATOR KITApdyne Medical Co.1989-10-12

Legacy Summary#

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FDA Review#

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