The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Capsule Delivery Device, 160cm, Model 711143; Capsule Delivery Device, 210cm, Model 711144.
| Device ID | K040494 |
| 510k Number | K040494 |
| Device Name: | CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144 |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Gretchen Y Cohen |
| Correspondent | Gretchen Y Cohen UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-06-23 |