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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 K875232
Device Name INTRO-REDUCER (NASOGASTRIC TUBE)
Applicant
Health Improvement Assoc.
12555 W. Freeland Rd.
Freeland,  MI  48623
Applicant Contact ALEXANDER BOMMARITO
Correspondent
Health Improvement Assoc.
12555 W. Freeland Rd.
Freeland,  MI  48623
Correspondent Contact ALEXANDER BOMMARITO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/22/1987
Decision Date 06/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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