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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 K926559
Device Name PROACT BIOPSY NEEDLE ENCHANCEMENTS
Applicant
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Applicant Contact ALLAN DARR
Correspondent
PROACT, LTD.
CALDER SQUARE BOX 11029
STATE COLLEGE,  PA  16805
Correspondent Contact ALLAN DARR
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/31/1992
Decision Date 03/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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