The following data is part of a premarket notification filed by Mri Manufacturing And Research, Inc. with the FDA for Endovive Low Profile Replacement Gastrostomy Tube, Model 82xx, 8283, 8284, 8285.
| Device ID | K083685 |
| 510k Number | K083685 |
| Device Name: | ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MRI MANUFACTURING AND RESEARCH, INC. 4700 SOUTH OVERLAND DR. Tucson, AZ 85714 |
| Contact | Suzanne Dew |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-06-25 |
| Summary: | summary |