510(k) K881133

Device
70-X/RVG (RADIOVISIOGRAPHY)
Applicant
TROPHY RADIOLOGIE
510(k) number
K881133
Product code
EHO  
Decision
Substantially Equivalent (SESE)
Decision date
1989-07-20
Date received
1988-03-16
Regulation
872.3165
Classification name
Bar, Preformed
Medical specialty
Dental
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JY SEVESTRE
Address
106, Rue De La Jarry B.P. 20 Vincennes, Cedex (Paris) FR 94307 94307

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934468SLIP-ON FIXATION SPLINT (SFS)Gatewood Splints1994-08-05
K883388DENTREK BRIDGE BARSDale T. Dupuis1988-10-06

Legacy Summary#

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FDA Review#

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