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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, malar
510(k) Number K980141
Device Name SPECTRUM DESIGNS PROJECTION MALAR 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
LZK  
Date Received01/15/1998
Decision Date 03/03/1998
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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