The following data is part of a premarket notification filed by Gi Supply with the FDA for Hp-fast.
| Device ID | K944903 |
| 510k Number | K944903 |
| Device Name: | HP-FAST |
| Classification | Helicobacter Pylori |
| Applicant | GI SUPPLY 423 N. 21ST ST. Camp Hill, PA 17011 |
| Contact | Frank Jackson |
| Correspondent | Frank Jackson GI SUPPLY 423 N. 21ST ST. 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 | 1994-10-04 |
| Decision Date | 1995-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893029002519 | K944903 | 000 |