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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K902320
Device Name BAUER FLEXI-TEMNO BIOPSY NEEDLE
Applicant
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Applicant Contact JOHN N ZINK
Correspondent
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Correspondent Contact JOHN N ZINK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/23/1990
Decision Date 10/01/1990
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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