The following data is part of a premarket notification filed by Minos Medical with the FDA for Megachannel Endoscopic Overtube, Model Ot22.
| Device ID | K080550 |
| 510k Number | K080550 |
| Device Name: | MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 |
| Classification | Endoscopic Contamination Prevention Sheath |
| Applicant | MINOS MEDICAL 15560-C ROCKFIELD BLVD Irvine, CA 92618 |
| Contact | Tom Colonna |
| Correspondent | Tom Colonna MINOS MEDICAL 15560-C ROCKFIELD BLVD Irvine, CA 92618 |
| Product Code | ODB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-06-10 |
| Summary: | summary |