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510(k) K780474

Device
AUDIOMETER CALIBRATOR MODEL RA 310
Applicant
TRACOR INSTRUMENTS, INC.
510(k) number
K780474
Product code
EWA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-30
Date received
1978-03-24
Regulation
874.1080
Classification name
Set, Audiometer Calibration
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 EWA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934432OTOVIEW ENDOSCOPY SYSTEMSmith & Nephew Richards, Inc.1994-04-25

Legacy Summary#

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FDA Review#

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