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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 K040042
Device Name MEDISIL SILICONE SHEETING
Applicant
Medisil Corporation
1735 N. Olive St.
Ventura,  CA  93001
Applicant Contact ALASTAIR WINN
Correspondent
Medisil Corporation
1735 N. Olive St.
Ventura,  CA  93001
Correspondent Contact ALASTAIR WINN
Regulation Number874.3620
Classification Product Code
MIB  
Date Received01/12/2004
Decision Date 04/01/2004
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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