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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Mechanical
510(k) Number K940238
Device Name TUMBLE FORMS JUNIOR TRISTANDER
Applicant
Camp Intl., Inc.
P.O. Box 89
Jackson,  MI  49204
Applicant Contact CONNIE STEVENS
Correspondent
Camp Intl., Inc.
P.O. Box 89
Jackson,  MI  49204
Correspondent Contact CONNIE STEVENS
Regulation Number890.3750
Classification Product Code
INW  
Date Received01/19/1994
Decision Date 03/07/1994
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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