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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Biopsy, Without Biopsy Instruments
510(k) Number K882673
Device Name SIGMA 1 WOBBLER BIOPSY KIT
Applicant
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Applicant Contact DAVID CROMWICK
Correspondent
KONTRON INSTRUMENTS, INC.
9 PLYMOUTH ST.
EVERETT,  MA  02149
Correspondent Contact DAVID CROMWICK
Regulation Number876.4730
Classification Product Code
FCH  
Date Received06/28/1988
Decision Date 07/28/1988
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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