The following data is part of a premarket notification filed by Manufacturing & Research, Inc. with the FDA for Mri's All Silicone Gastrostomy Tube.
| Device ID | K951489 |
| 510k Number | K951489 |
| Device Name: | MRI'S ALL SILICONE GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MANUFACTURING & RESEARCH, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb MANUFACTURING & RESEARCH, INC. P.O. BOX 2308 1247 FLORIDA AVENUE Palm Harbor, FL 34682 -2308 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-31 |
| Decision Date | 1995-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521141346 | K951489 | 000 |
| 10884521141339 | K951489 | 000 |
| 20884521141329 | K951489 | 000 |
| 20884521141312 | K951489 | 000 |
| 20884521141367 | K951489 | 000 |
| 20884521141350 | K951489 | 000 |