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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Band, Material, Orthodontic
510(k) Number K844034
Device Name SONOCARE
Applicant
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Applicant Contact FRANK L SAYLOR
Correspondent
Echo Ultrasound
Post Office Box 552
Lewistown,  PA  17044
Correspondent Contact FRANK L SAYLOR
Regulation Number872.5410
Classification Product Code
DYO  
Date Received10/16/1984
Decision Date 01/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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