The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Foreign Body Hood.
| Device ID | K130148 |
| 510k Number | K130148 |
| Device Name: | FOREIGN BODY HOOD |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 Heisley Rd Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 Heisley Rd Mentor, OH 44060 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-22 |
| Decision Date | 2013-08-07 |