The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Magnaflow Magnetically Guided Enteral Feeding Tube.
| Device ID | K021991 |
| 510k Number | K021991 |
| Device Name: | MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SYNCRO MEDICAL INNOVATIONS, INC. 433 CHERRY STREET, LL#6 Macon, GA 31201 -7950 |
| Contact | Sabry A Gabriel |
| Correspondent | Sabry A Gabriel SYNCRO MEDICAL INNOVATIONS, INC. 433 CHERRY STREET, LL#6 Macon, GA 31201 -7950 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-07-18 |
| Summary: | summary |