Definition: Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa.
| Device Type ID | 2230 |
| Device Name | Protective Coating, Mucoadhesive Application, For 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | PHN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2230 |
| Device | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Product Code | PHN |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCESS PHARMACEUTICALS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |