The following data is part of a premarket notification filed by Oral Biotech with the FDA for Oral Neutralizer.
| Device ID | K071617 |
| 510k Number | K071617 |
| Device Name: | ORAL NEUTRALIZER |
| Classification | Saliva, Artificial |
| Applicant | ORAL BIOTECH 812 WATER ST. NE Albany, OR 97321 |
| Contact | Robert Bowers |
| Correspondent | Robert Bowers ORAL BIOTECH 812 WATER ST. NE Albany, OR 97321 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-13 |
| Decision Date | 2007-10-19 |
| Summary: | summary |