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510(k) K832946

Device
DALE ENDOTRACHEAL TUBE HOLDER
Applicant
DALE MEDICAL PRODUCTS, INC.
510(k) number
K832946
Product code
JAY  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-14
Date received
1983-09-02
Regulation
868.5280
Classification name
Support, Breathing Tube
Medical specialty
Anesthesiology
Review panel
Anesthesiology
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 JAY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944988CUSTOM MEDICAL SUSPENSION STRAPCustom Medical Specialties, Inc.1995-01-27
K873491BLOCK, BITE, INTUBATIONB&B Medical Technologies, Inc.1987-10-20
K860583DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315Dale Medical Products, Inc.1986-02-21
K850924JEE FRAME (VENTILATOR CIRCUIT SUPPORT)Vulcan Laboratories, Inc.1985-07-19
K850309COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCKAckrad Laboratories1985-02-14
K840844ENDO-SECUREExidyne, Inc.1984-03-16
K834265TRACH MATETempe Biomedical, Inc.1984-01-04
K834089COMFITAckrad Laboratories1983-12-29
K833361TUBE-TITLESontek Industries, Inc.1983-11-03
K833374BITE-BLOCKSontek Industries, Inc.1983-11-03
K833332SCHULTZ ENDHOLDPolyclinic Medical Center1983-10-31
K802675ENDOTRACHEAL TUBE HOLDERRespiratory Support Products, Inc.1980-11-19
K792148ADJUSTABLE TUBE TREE FOR ANESTH. HOSESMedical Innovations Corp.1979-11-15
K791781TUBE-STRAPOlympic Medical Corp.1979-09-19
K790410ADULT ZEE-FRAMEEquilibrated Bio Systems, Inc.1979-03-22

Legacy Summary#

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FDA Review#

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