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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 K944166
Device Name DORSAL COLUMELLA 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  
Subsequent Product Codes
FWP   FZE  
Date Received08/26/1994
Decision Date 11/04/1994
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
Recalls CDRH Recalls
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