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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, External Aesthetic Restoration, Used With Adhesive
510(k) Number K831831
Device Name TRULIFE SILICONE BREAST FORM
Applicant
MEDEERING, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDEERING, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3800
Classification Product Code
GBI  
Date Received06/07/1983
Decision Date 06/30/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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