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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 K923488
Device Name GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY
Applicant
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Applicant Contact DONNA BRESSAN
Correspondent
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Correspondent Contact DONNA BRESSAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/15/1992
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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