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510(k) K897049

Device
GIBSON ENDOLYMPHATIC SHUNT
Applicant
HOOD LABORATORIES
510(k) number
K897049
Product code
ESZ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-16
Date received
1989-12-18
Regulation
874.3820
Classification name
Tube, Shunt, Endolymphatic
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEWIS H MARTEN
Address
575 Washington St. Pembroke MA US 02359 02359

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ESZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974224ENDOLYMPHATIC SAC TO MASTOID T-SHUNTExmoor Plastics , Ltd.1998-01-27
K952227C-FLEX ENDOLYMPHATIC SHUNTTrebay Medical Corp.1995-06-16
K834094AUSTIN ENDOLYMPH DISPERSMENT SHUNTTreace Medical, Inc.1984-09-20

Legacy Summary#

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FDA Review#

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