The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Enteroscopy Overtube, Model 00712140.
| Device ID | K100081 |
| 510k Number | K100081 |
| Device Name: | ENTEROSCOPY OVERTUBE, MODEL 00712140 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Bob Bishui |
| Correspondent | Bob Bishui UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-04-12 |
| Summary: | summary |