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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K982067
Device Name MAGNETIC PORT SILICONE TISSUE EXPANDER
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
Classification Product Code
LCJ  
Date Received06/12/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
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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