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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, Suction
510(k) Number K911448
Device Name MULTIPLE BIOPSY DEVICE-MBX
Applicant
TRITON TECHNOLOGY, INC.
2380 SOUTHEAST BLVD.
SALEM,  OH  44460
Applicant Contact WILLIAM Z KOLOZSI
Correspondent
TRITON TECHNOLOGY, INC.
2380 SOUTHEAST BLVD.
SALEM,  OH  44460
Correspondent Contact WILLIAM Z KOLOZSI
Regulation Number876.1075
Classification Product Code
FCK  
Date Received03/15/1991
Decision Date 04/16/1991
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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