The following data is part of a premarket notification filed by Endovations with the FDA for Endoscopic Retrograde Cholangiopancreatography.
| Device ID | K860990 |
| 510k Number | K860990 |
| Device Name: | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lifton, Md |
| Correspondent | Lifton, Md ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-05-13 |