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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K901971
Device Name COMFORTRAC TABLE MODEL CT-1000
Applicant
Comfortrac Systems
2944 I-70 Business Loop #208
Grand Junction,  CO  81504
Applicant Contact ROBERT W NICKS
Correspondent
Comfortrac Systems
2944 I-70 Business Loop #208
Grand Junction,  CO  81504
Correspondent Contact ROBERT W NICKS
Regulation Number890.5880
Classification Product Code
JFB  
Date Received05/01/1990
Decision Date 07/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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