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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 K990515
Device Name MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
Applicant
International Medical Systems
P.O. Box 4936
Annapolis,  MD  21403
Correspondent
International Medical Systems
P.O. Box 4936
Annapolis,  MD  21403
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/18/1999
Decision Date 05/13/1999
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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