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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Muscle, Pectoralis
510(k) Number K944163
Device Name SPECTRUM DISIGNS PECTORAL 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 Number874.3620
Classification Product Code
MIC  
Date Received08/26/1994
Decision Date 11/07/1994
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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