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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 K873360
Device Name ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
Applicant
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Applicant Contact SUSAN P BJORKMAN
Correspondent
Endovations
895 Poplar Church Rd.
Camp Hill,  PA  17011
Correspondent Contact SUSAN P BJORKMAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/21/1987
Decision Date 03/30/1988
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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