The following data is part of a premarket notification filed by Syncro Medical Innovations, Inc. with the FDA for Syncro - Blue Tube, The Magnetically Guided Enteral Feeding Tube- 8fr Tube.
| Device ID | K110005 |
| 510k Number | K110005 |
| Device Name: | SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SYNCRO MEDICAL INNOVATIONS, INC. 342 E MAIN STREET, SUITE 207 Leola, PA 17540 |
| Contact | William G Mclain |
| Correspondent | William G Mclain SYNCRO MEDICAL INNOVATIONS, INC. 342 E MAIN STREET, SUITE 207 Leola, PA 17540 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-08-04 |
| Summary: | summary |