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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, chin, internal
510(k) Number K980445
Device Name SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
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 Number878.3550
Classification Product Code
FWP  
Date Received02/05/1998
Decision Date 05/06/1998
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
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