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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 K863884
Device Name PULSESTAR EXERCISE BIKE
Applicant
Battle Creek Equipment Co.
307 W. Jackson St.
Battle Creek,  MI  49017
Applicant Contact JOHN W DOTY
Correspondent
Battle Creek Equipment Co.
307 W. Jackson St.
Battle Creek,  MI  49017
Correspondent Contact JOHN W DOTY
Regulation Number890.5360
Classification Product Code
ISD  
Date Received10/06/1986
Decision Date 10/23/1986
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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