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510(k) K923679

Device
ENDOPATH TISSUE RETAINING COMPONENT
Applicant
ETHICON ENDO-SURGERY, INC.
510(k) number
K923679
Product code
KCJ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-09
Date received
1992-07-22
Regulation
874.5220
Classification name
Applicator, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MELISSA WALKER
Address
4545 Creek Rd. Cincinnati OH US 45242 45242

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KCJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921053LAPAROMED LIGATING LOOPLaparomed Corp.1992-08-06
K894369APDYNE PHENOL APPLICATOR KITApdyne Medical Co.1989-10-12
K832667LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.1983-09-29

Legacy Summary#

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FDA Review#

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