The following data is part of a premarket notification filed by Concord/portex with the FDA for Oral Pharyngeal Cleansing Device.
| Device ID | K905011 |
| 510k Number | K905011 |
| Device Name: | ORAL PHARYNGEAL CLEANSING DEVICE |
| Classification | Unit, Operative Dental |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-07 |
| Decision Date | 1991-01-31 |