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510(k) K862903

Device
MIDDLE EAR VIEWER AND FLUID COLLECTOR
Applicant
STEVEN K. JUHN
510(k) number
K862903
Product code
JZF  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-24
Date received
1986-07-31
Regulation
874.4420
Classification name
Tube, Ear Suction
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BARTZ &
Address
Gutenkauf 1300 Foshay Tower Minneapolis MN US 55402 55402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973587EXMOOR TYMPANOCENTESIS KIT (TK/1)Exmoor Plastics , Ltd.1998-01-23
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#

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FDA Review#

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