The following data is part of a premarket notification filed by Abbott Research Group, Inc. with the FDA for Water Works Douching Device.
| Device ID | K080200 |
| 510k Number | K080200 |
| Device Name: | WATER WORKS DOUCHING DEVICE |
| Classification | Douche Apparatus, Vaginal, Therapeutic |
| Applicant | ABBOTT RESEARCH GROUP, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson ABBOTT RESEARCH GROUP, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | HED |
| CFR Regulation Number | 884.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-07-10 |
| Summary: | summary |