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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Nonpowered
510(k) Number K812778
Device Name THE TELOS EQUIPMENT
Applicant
The Telos Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Telos Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.1520
Classification Product Code
KQW  
Date Received10/05/1981
Decision Date 12/08/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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