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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 K991312
Device Name SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
Applicant
Library Medical, Inc.
60 Terence Dr.
Pittsburgh,  PA  15236
Applicant Contact RICHARD A HARTMAN
Correspondent
Library Medical, Inc.
60 Terence Dr.
Pittsburgh,  PA  15236
Correspondent Contact RICHARD A HARTMAN
Regulation Number878.4025
Classification Product Code
MDA  
Date Received04/16/1999
Decision Date 08/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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