510(k) K974224

Device: ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
Applicant: EXMOOR PLASTICS LTD.
510(k) number: K974224
Product code: ESZ
Decision: Substantially Equivalent (SESE)
Decision date: 1998-01-27
Date received: 1997-11-10
Regulation: 874.3820
Classification name: Tube, Shunt, Endolymphatic
Medical specialty: Ear Nose & Throat
Review panel: Ear Nose & Throat
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARGARET BLACKMORE
Address: Lisieux Way Taunton GB TA1 2LB TA1 2LB

FDA Registration Numbers#

1048735
3018094310
1045254

Source Documents#

Other 510(k) Records For Product Code ESZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K952227	C-FLEX ENDOLYMPHATIC SHUNT	Trebay Medical Corp.	1995-06-16
K897049	GIBSON ENDOLYMPHATIC SHUNT	Hood Laboratories	1990-03-16
K834094	AUSTIN ENDOLYMPH DISPERSMENT SHUNT	Treace Medical, Inc.	1984-09-20

Legacy Summary#

summary

FDA Review#

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