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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Nasogastric
510(k) Number K934348
Device Name TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR
Applicant
TRI-MED SPECIALTIES, INC.
P.O. BOX 23306
OVERLAND PARK,  KS  66223
Applicant Contact LARRY SCOTT
Correspondent
TRI-MED SPECIALTIES, INC.
P.O. BOX 23306
OVERLAND PARK,  KS  66223
Correspondent Contact LARRY SCOTT
Regulation Number876.5980
Classification Product Code
BSS  
Date Received09/07/1993
Decision Date 12/23/1994
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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