The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Concentric Balloon Google.
| Device ID | K112698 |
| 510k Number | K112698 |
| Device Name: | CONCENTRIC BALLOON GOOGLE |
| Classification | Endoscope Channel Accessory |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Carroll L Martin |
| Correspondent | Carroll L Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-16 |
| Decision Date | 2012-05-18 |