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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 Block
510(k) Number K960038
Device Name SPECTRUM DESIGNS SILICONE BLOCK
Applicant
SPECTRUM DESIGNS, INC.
5921 MATTHEWS ST.
UNIT C
GOLETA,  CA  93117
Applicant Contact JIM DISHMAN
Correspondent
SPECTRUM DESIGNS, INC.
5921 MATTHEWS ST.
UNIT C
GOLETA,  CA  93117
Correspondent Contact JIM DISHMAN
Regulation Number874.3620
Classification Product Code
MIB  
Date Received01/03/1996
Decision Date 03/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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