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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 K991478
Device Name TENDER TOUCH SILICONE GEL PADS
Applicant
Capital Marketing Technologies, Inc.
3630 S. I-35, Suite A
Waco,  TX  76706
Applicant Contact JOHN SNYDER
Correspondent
Capital Marketing Technologies, Inc.
3630 S. I-35, Suite A
Waco,  TX  76706
Correspondent Contact JOHN SNYDER
Regulation Number878.4025
Classification Product Code
MDA  
Subsequent Product Code
FMP  
Date Received04/28/1999
Decision Date 06/21/1999
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 No
Predetermined Change
Control Plan Authorized		 No
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