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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 K974654
Device Name SILICONE BLOCKS
Applicant
Specialty Surgical Products, Inc.
302 N. First St.
Hamilton,  MT  59840
Applicant Contact T. JAN VARNER
Correspondent
Specialty Surgical Products, Inc.
302 N. First St.
Hamilton,  MT  59840
Correspondent Contact T. JAN VARNER
Regulation Number874.3620
Classification Product Code
MIB  
Date Received12/15/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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