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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 K970702
Device Name SPECTRUM DESIGNS SPECTRAGEL
Applicant
Spectrum Designs, Inc.
5921 C. Matthews St.
Goleta,  CA  93117
Applicant Contact JIM DISHMAN
Correspondent
Spectrum Designs, Inc.
5921 C. Matthews St.
Goleta,  CA  93117
Correspondent Contact JIM DISHMAN
Regulation Number878.4025
Classification Product Code
MDA  
Date Received02/26/1997
Decision Date 05/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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