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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K822212
Device Name MOTORIZED EXERCISER
Applicant
W.R. MCCULLIN
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
W.R. MCCULLIN
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number890.5380
Classification Product Code
BXB  
Date Received07/26/1982
Decision Date 08/31/1982
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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