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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 K983043
Device Name SEARE BIOMEDICAL SILICONE BLOCK
Applicant
Seare Biomedical Corp.
3190 Chula Vista Cir.
Salt Lake City,  UT  84121
Applicant Contact WILLIAM J SEARE, JR
Correspondent
Seare Biomedical Corp.
3190 Chula Vista Cir.
Salt Lake City,  UT  84121
Correspondent Contact WILLIAM J SEARE, JR
Regulation Number874.3620
Classification Product Code
MIC  
Date Received08/31/1998
Decision Date 09/30/1998
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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