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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 K991957
Device Name CICACARE MANAGEMENT FOR SCARS
Applicant
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Applicant Contact JIM IRVIN
Correspondent
Smith & Nephew, Inc.
11775 Starkey Rd.
Largo,  FL  33773
Correspondent Contact JIM IRVIN
Regulation Number878.4025
Classification Product Code
MDA  
Date Received06/10/1999
Decision Date 07/20/1999
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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