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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 K941256
Device Name QUICK CORE II
Applicant
Proact, Ltd.
Calder Sq. Box 11029
State College,  PA  16805
Applicant Contact ALLAN DARR
Correspondent
Proact, Ltd.
Calder Sq. Box 11029
State College,  PA  16805
Correspondent Contact ALLAN DARR
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received03/14/1994
Decision Date 07/13/1994
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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