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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 K973730
Device Name DURASIL I AND DURASIL II
Applicant
Hanson Medical, Inc.
19325 58th Pl., NE
Seattle,  WA  98155
Applicant Contact GERALD HANSON
Correspondent
Hanson Medical, Inc.
19325 58th Pl., NE
Seattle,  WA  98155
Correspondent Contact GERALD HANSON
Regulation Number874.3620
Classification Product Code
MIB  
Date Received09/30/1997
Decision Date 12/24/1997
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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