The following data is part of a premarket notification filed by Gi Supply with the FDA for Hp-one.
| Device ID | K012411 |
| 510k Number | K012411 |
| Device Name: | HP-ONE |
| Classification | Helicobacter Pylori |
| Applicant | GI SUPPLY 200 GRANDVIEW AVE. Camp Hill, PA 17011 |
| Contact | Frank Carter |
| Correspondent | Frank Carter GI SUPPLY 200 GRANDVIEW AVE. Camp Hill, PA 17011 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893029002571 | K012411 | 000 |
| 00893029002502 | K012411 | 000 |