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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 K984115
Device Name SCAREASE & SCAREASE ADHESIVE GEL
Applicant
Scarease, Inc.
P.O. Box 500356
Poway,  CA  92150
Applicant Contact TED HARTLEY
Correspondent
Scarease, Inc.
P.O. Box 500356
Poway,  CA  92150
Correspondent Contact TED HARTLEY
Regulation Number878.4025
Classification Product Code
MDA  
Date Received11/17/1998
Decision Date 02/12/1999
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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