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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 K902319
FOIA Releasable 510(k) K902319
Device Name BAUER TEMNO BIOPSY NEEDLE
Applicant
Proact, Ltd.
Calder Sq. Box 11029
State College,  PA  16805
Applicant Contact JOHN N ZINK
Correspondent
Proact, Ltd.
Calder Sq. Box 11029
State College,  PA  16805
Correspondent Contact JOHN N ZINK
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/23/1990
Decision Date 09/06/1990
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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