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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 K923692
Device Name STOMA MEASURING DEVICE
Applicant
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Applicant Contact PAT GILPIN
Correspondent
APPLIED MEDICAL TECHNOLOGIES
6100 WEST CREEK RD.
SUITE 25
INDEPENDENCE,  OH  44131
Correspondent Contact PAT GILPIN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/23/1992
Decision Date 05/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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