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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name brush, biopsy, general & plastic surgery
510(k) Number K792316
Device Name TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
Applicant
URSUS KONSULT AB
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
URSUS KONSULT AB
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GEE  
Date Received11/16/1979
Decision Date 12/18/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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