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510(k) K841357

Device
MICRO FLUID APPLICATOR
Applicant
TREACE MEDICAL, INC.
510(k) number
K841357
Product code
JZF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-24
Date received
1984-04-02
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K862903MIDDLE EAR VIEWER AND FLUID COLLECTORSteven K. Juhn1986-11-24
K853589SHAH SELF-CLEARING MASTOID SUCTION TUBEDowns Surgical , Ltd.1985-12-23
K822010RIGID SUCTION TIPS & RELATED ITEMSKelleher Corp.1982-08-12

Legacy Summary#

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FDA Review#

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