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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 K882867
Device Name CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
Applicant
Corpak Co.
100 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact ROBERT B EDWARDS
Correspondent
Corpak Co.
100 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact ROBERT B EDWARDS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/11/1988
Decision Date 09/21/1988
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
Recalls CDRH Recalls
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