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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 K921478
Device Name GUARDPORT
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 Received03/30/1992
Decision Date 01/11/1995
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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