FDA.reportPublic FDA data

510(k) K853589

Device
SHAH SELF-CLEARING MASTOID SUCTION TUBE
Applicant
DOWNS SURGICAL LTD.
510(k) number
K853589
Product code
JZF  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-23
Date received
1985-08-27
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
JARVIS CRIBB
Address
42 Industrial Way Wilmington MA US 01887 01887

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
K841357MICRO FLUID APPLICATORTreace Medical, Inc.1984-08-24
K822010RIGID SUCTION TIPS & RELATED ITEMSKelleher Corp.1982-08-12

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases