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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Surgical, General & Plastic Surgery
510(k) Number K972521
Device Name NAVIGATOR (STYLET) 2006
Applicant
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Applicant Contact KAREN K SYLVIA
Correspondent
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Correspondent Contact KAREN K SYLVIA
Regulation Number878.4800
Classification Product Code
GAH  
Date Received07/07/1997
Decision Date 10/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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