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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name elastomer, silicone, for scar management
510(k) Number K041704
Device Name NEWGEL AND NEWGEL PLUS E
Applicant
NEWMEDICAL TECHNOLOGY, INC.
3324 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Applicant Contact HAITHAM MATLOUB
Correspondent
NEWMEDICAL TECHNOLOGY, INC.
3324 COMMERCIAL AVENUE
NORTHBROOK,  IL  60062
Correspondent Contact HAITHAM MATLOUB
Regulation Number878.4025
Classification Product Code
MDA  
Date Received06/23/2004
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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