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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K910584
Device Name ONE STEP BUTTON(TM)
Applicant
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Applicant Contact PAT GILPIN
Correspondent
Applied Medical Technologies
6100 W. Creek Rd.
Suite 25
Independence,  OH  44131
Correspondent Contact PAT GILPIN
Regulation Number876.5980
Classification Product Code
KGC  
Date Received02/11/1991
Decision Date 05/23/1991
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
Recalls CDRH Recalls
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