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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K040087
Device Name RABBIT
Applicant
Scion International, Inc.
7930 Hwy 22
Meridian,  TX  76665
Applicant Contact C. KENNETH FRENCH
Correspondent
Scion International, Inc.
7930 Hwy 22
Meridian,  TX  76665
Correspondent Contact C. KENNETH FRENCH
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/16/2004
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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