The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Disposable Overtube.
| Device ID | K040836 |
| 510k Number | K040836 |
| Device Name: | DISPOSABLE OVERTUBE |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| 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 | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012052 | K040836 | 000 |
| 00724995184506 | K040836 | 000 |
| 10724995183612 | K040836 | 000 |
| 10724995183629 | K040836 | 000 |
| 10724995183636 | K040836 | 000 |
| 10724995183643 | K040836 | 000 |
| 10816765012021 | K040836 | 000 |
| 10816765012038 | K040836 | 000 |
| 10816765012045 | K040836 | 000 |
| 00724995184490 | K040836 | 000 |