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510(k) K905657

Device
SONOPAK/QS, SONOPAK
Applicant
BIORESEARCH
510(k) number
K905657
Product code
NFQ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-05-15
Date received
1990-12-17
Regulation
872.2050
Classification name
Device, Dental Sonography, For Monitoring Jaw Sounds
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN RADKE
Address
4113 N. Port Washington Rd. Milwaukee WI US 53212 53212

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NFQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970116ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.1997-04-02
K905449ELECTROSONOGRAM ESG-1Myo-Tronics, Inc.1991-04-26
K862286ARTHROPHONOMETERArthrotek, Inc.1987-01-07

Legacy Summary#

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FDA Review#

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