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U.S. Department of Health and Human Services

Product Classification

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Device protective coating, mucoadhesive application, for the rectal mucosa
Definition Mucoadhesive application for the protective coating of the rectal mucosa.
Physical State viscous liquid
Technical Method applied via enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.
Target Area rectum
Review Panel Gastroenterology/Urology
Product CodePHN
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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