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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Trap, Sterile Specimen
510(k) Number K902883
Device Name TISSUE/POLYP TRAP SYSTEM
Applicant
Triton Technology, Inc.
2380 Southeast Blvd.
Salem,  OH  44460
Applicant Contact Z KOLOZSI,MD
Correspondent
Triton Technology, Inc.
2380 Southeast Blvd.
Salem,  OH  44460
Correspondent Contact Z KOLOZSI,MD
Regulation Number880.6740
Classification Product Code
BYZ  
Date Received07/02/1990
Decision Date 09/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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