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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 K945618
Device Name GASTROINTESTINAL TUBES & ACCESSORIES
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 Received11/15/1994
Decision Date 10/12/1995
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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