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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, chin, internal
510(k) Number K982752
Device Name SEARE BIOMEDICAL CHIN IMPLANTS
Applicant
SEARE BIOMEDICAL CORP.
3190 CHULA VISTA CIRCLE
SALT LAKE CITY,  UT  84121
Applicant Contact WILLIAM JOHN SEARE JR
Correspondent
SEARE BIOMEDICAL CORP.
3190 CHULA VISTA CIRCLE
SALT LAKE CITY,  UT  84121
Correspondent Contact WILLIAM JOHN SEARE JR
Regulation Number878.3550
Classification Product Code
FWP  
Date Received08/06/1998
Decision Date 09/30/1998
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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