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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 K983041
Device Name SEARE BIOMEDICAL SILICONE SHEETING
Applicant
SEARE BIOMEDICAL CORP.
3190 CHULA VISTA CIRCLE
SALT LAKE CITY,  UT  84121
Applicant Contact WILLIAM J SEARE, JR
Correspondent
SEARE BIOMEDICAL CORP.
3190 CHULA VISTA CIRCLE
SALT LAKE CITY,  UT  84121
Correspondent Contact WILLIAM J SEARE, JR
Regulation Number874.3620
Classification Product Code
MIB  
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
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