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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 K892071
Device Name GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE
Applicant
AMEDIC USA
OXENSTIERNSGATAN 31
115 27 STOCKHOLM
SWEDEN,  SE
Applicant Contact ANDERS WEILANDT
Correspondent
AMEDIC USA
OXENSTIERNSGATAN 31
115 27 STOCKHOLM
SWEDEN,  SE
Correspondent Contact ANDERS WEILANDT
Regulation Number876.1075
Classification Product Code
KNW  
Date Received03/31/1989
Decision Date 08/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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