The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Eus Balloon.
| Device ID | K111028 |
| 510k Number | K111028 |
| Device Name: | EUS BALLOON |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| 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 | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-13 |
| Decision Date | 2011-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765011932 | K111028 | 000 |
| 10724995184107 | K111028 | 000 |