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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K983366
Device Name TRIP TONOMETRY CATHETER, 16F
Applicant
DATEX-ENGSTROM, INC.
3 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL KENT
Correspondent
DATEX-ENGSTROM, INC.
3 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Codes
CBR   CCK  
Date Received09/24/1998
Decision Date 12/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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