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510(k) K973587

Device
EXMOOR TYMPANOCENTESIS KIT (TK/1)
Applicant
EXMOOR PLASTICS LTD.
510(k) number
K973587
Product code
JZF  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-23
Date received
1997-09-22
Regulation
874.4420
Classification name
Tube, Ear Suction
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
MARGARET BLACKMORE
Address
Lisieux Way Taunton GB TA1 2LB TA1 2LB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862903MIDDLE EAR VIEWER AND FLUID COLLECTORSteven K. Juhn1986-11-24
K853589SHAH SELF-CLEARING MASTOID SUCTION TUBEDowns Surgical , Ltd.1985-12-23
K841357MICRO FLUID APPLICATORTreace Medical, Inc.1984-08-24
K822010RIGID SUCTION TIPS & RELATED ITEMSKelleher Corp.1982-08-12

Legacy Summary#

summary

FDA Review#

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