The following data is part of a premarket notification filed by Showerfloss, Inc. with the FDA for Showerfloss Oral Irrigation Unit.
| Device ID | K922307 |
| 510k Number | K922307 |
| Device Name: | SHOWERFLOSS ORAL IRRIGATION UNIT |
| Classification | Unit, Oral Irrigation |
| Applicant | SHOWERFLOSS, INC. 26300 HICKORY BLVD #1105 Bonita Springs, FL 33923 |
| Contact | Clyde F Stewart |
| Correspondent | Clyde F Stewart SHOWERFLOSS, INC. 26300 HICKORY BLVD #1105 Bonita Springs, FL 33923 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1992-06-16 |