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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 K831582
Device Name VARI-SUPPORT NECK POSTURE PILLOW
Applicant
Body Therapeutics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Body Therapeutics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IQK  
Date Received05/17/1983
Decision Date 06/15/1983
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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