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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cephalometer
510(k) Number K870243
Device Name BURNETT TMJ APPLIANCE
Applicant
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact RUEY C DEMPSEY
Correspondent
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact RUEY C DEMPSEY
Regulation Number872.1830
Classification Product Code
EAG  
Date Received01/21/1987
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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