The following data is part of a premarket notification filed by Manufacturing & Research, Inc. with the FDA for Endo Vive Standard Replacement Gastrostomy Tube, Model 82xx.
| Device ID | K083684 |
| 510k Number | K083684 |
| Device Name: | ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MANUFACTURING & RESEARCH, INC. 4700 SOUTH OVERLAND DR. Tucson, AZ 85745 |
| Contact | Suzanne Dew |
| 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 | 2009-02-05 |
| Summary: | summary |