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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 K932142
Device Name SUCTION GUILLOTINE DEVICE
Applicant
TRITON TECHNOLOGY, INC.
2380 SOUTHEAST BLVD.
SALEM,  OH  44460
Applicant Contact WILLIAM KOLOZSI
Correspondent
TRITON TECHNOLOGY, INC.
2380 SOUTHEAST BLVD.
SALEM,  OH  44460
Correspondent Contact WILLIAM KOLOZSI
Regulation Number876.1075
Classification Product Code
FCK  
Date Received05/03/1993
Decision Date 09/24/1993
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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