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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name protective coating, mucoadhesive application, for the rectal mucosa
510(k) Number K140558
Device Name PROCTIGARD
Applicant
ACCESS PHARMACEUTICALS, INC
1325 AVENUE OF THE AMERICA, 27TH FLOOR
NEW YORK,  NY  10019
Applicant Contact JEFFREY B DAVIS
Correspondent
ACCESS PHARMACEUTICALS, INC
1325 AVENUE OF THE AMERICA, 27TH FLOOR
NEW YORK,  NY  10019
Correspondent Contact JEFFREY B DAVIS
Classification Product Code
PHN  
Date Received03/05/2014
Decision Date 07/16/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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