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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K792591
Device Name STRESS TABLE/ERGOMETER SYSTEM
Applicant
Victoreen, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Victoreen, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5360
Classification Product Code
ISD  
Date Received12/17/1979
Decision Date 01/04/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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