The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Ercp Cannula.
| Device ID | K924107 |
| 510k Number | K924107 |
| Device Name: | ERCP CANNULA |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094 |
| Contact | Marlin Younker |
| Correspondent | Marlin Younker UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1992-12-30 |