The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Irrigation System.
| Device ID | K103239 |
| 510k Number | K103239 |
| Device Name: | IRRIGATION SYSTEM |
| Classification | Endoscopic Irrigation/suction System |
| 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 | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-02 |
| Decision Date | 2010-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995183995 | K103239 | 000 |
| 10724995183957 | K103239 | 000 |
| 10724995216839 | K103239 | 000 |