The following data is part of a premarket notification filed by Maulin Medical Llc with the FDA for Guardian Connection.
| Device ID | K101214 |
| 510k Number | K101214 |
| Device Name: | GUARDIAN CONNECTION |
| Classification | Tube, Feeding |
| Applicant | MAULIN MEDICAL LLC 486 E. GENTRY DRIVE Pueblo West, CO 81007 |
| Contact | Sara Owens |
| Correspondent | Sara Owens MAULIN MEDICAL LLC 486 E. GENTRY DRIVE Pueblo West, CO 81007 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-30 |
| Decision Date | 2010-07-23 |
| Summary: | summary |