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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Truncal, Pregnancy
510(k) Number K821836
Device Name PREGNANCY (W) EDGE
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
QSB  
Date Received06/22/1982
Decision Date 07/30/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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