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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sensing, Optical Contour
510(k) Number K851133
Device Name TERRAN BIOMECHANICAL ANALYSIS SYSTEM
Applicant
Terran Biomedical Instruments
1520 24th. St. NE
Salem,  OR  97301
Applicant Contact SCOTT ELLIOT
Correspondent
Terran Biomedical Instruments
1520 24th. St. NE
Salem,  OR  97301
Correspondent Contact SCOTT ELLIOT
Classification Product Code
LDK  
Date Received03/21/1985
Decision Date 06/19/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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