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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 K973729
Device Name POWERFLEX PEC IMPLANT
Applicant
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Applicant Contact ERIK HANSON
Correspondent
HANSON MEDICAL, INC.
P.O. BOX 1160
KINGSTON,  WA  98346
Correspondent Contact ERIK HANSON
Regulation Number874.3620
Classification Product Code
MIC  
Date Received09/30/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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