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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K030809
Device Name HANSON MEDICAL GLUTEAL IMPLANT
Applicant
Hanson Medical, Inc.
5662 Calle Real, #331
Goleta,  CA  93117
Applicant Contact JOHN HARRISON
Correspondent
Hanson Medical, Inc.
5662 Calle Real, #331
Goleta,  CA  93117
Correspondent Contact JOHN HARRISON
Regulation Number874.3620
Classification Product Code
MIB  
Date Received03/13/2003
Decision Date 04/21/2003
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
Predetermined Change
Control Plan Authorized		 No
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