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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 K852535
Device Name E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY
Applicant
Tri-Med Specialties, Inc.
P.O. Box 23306
Overland Park,  KS  66223
Applicant Contact W. A FRY
Correspondent
Tri-Med Specialties, Inc.
P.O. Box 23306
Overland Park,  KS  66223
Correspondent Contact W. A FRY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/14/1985
Decision Date 10/17/1985
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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