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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cervical
510(k) Number K882264
Device Name BATTLE CREEK PILLOW
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 Number890.3490
Classification Product Code
IQK  
Date Received05/31/1988
Decision Date 08/09/1988
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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