The following data is part of a premarket notification filed by Arj Medical, Inc. with the FDA for Pylo-plus.
| Device ID | K052708 |
| 510k Number | K052708 |
| Device Name: | PYLO-PLUS |
| Classification | Helicobacter Pylori |
| Applicant | ARJ MEDICAL, INC. 209 STATE STREET Oldsmar, FL 34677 |
| Contact | Philip Ross |
| Correspondent | Philip Ross ARJ MEDICAL, INC. 209 STATE STREET Oldsmar, FL 34677 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2006-05-01 |