The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Ercp Cannula.
| Device ID | K963051 |
| 510k Number | K963051 |
| Device Name: | ERCP CANNULA |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen Younker-cohen |
| Correspondent | Gretchen Younker-cohen UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-06 |
| Decision Date | 1997-03-28 |
| Summary: | summary |