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510(k) K894369

Device
APDYNE PHENOL APPLICATOR KIT
Applicant
APDYNE MEDICAL CO.
510(k) number
K894369
Product code
KCJ  
Decision
Substantially Equivalent - With Drug (SESD)
Decision date
1989-10-12
Date received
1989-07-14
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#

Contact
MICHAEL W WALSH
Address
955 W. Idaho Ave. Saint Paul MN US 55117 55117

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
K832667LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.1983-09-29

Legacy Summary#

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FDA Review#

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