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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 K992522
Device Name SPECTRUM DESIGNS SPECTRAGEL
Applicant
Spectrum Designs, Inc.
6387 B Rose Ln.
Carpineteria,  CA  93013
Applicant Contact JIM DISHMAN
Correspondent
Spectrum Designs, Inc.
6387 B Rose Ln.
Carpineteria,  CA  93013
Correspondent Contact JIM DISHMAN
Regulation Number878.4025
Classification Product Code
MDA  
Date Received07/28/1999
Decision Date 10/26/1999
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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