The following data is part of a premarket notification filed by Mondeal North America, Inc with the FDA for Mondeal Endoscopic Tissue Recession And Release System.
| Device ID | K072684 |
| 510k Number | K072684 |
| Device Name: | MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | MONDEAL NORTH AMERICA, INC PO BOX 500521 San Diego, CA 92150 |
| Contact | Jay Evans |
| Correspondent | Jay Evans MONDEAL NORTH AMERICA, INC PO BOX 500521 San Diego, CA 92150 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-21 |
| Decision Date | 2008-01-04 |
| Summary: | summary |