The following data is part of a premarket notification filed by Bouvier Hydro, Inc. with the FDA for Vichy Shower.
| Device ID | K980909 |
| 510k Number | K980909 |
| Device Name: | VICHY SHOWER |
| Classification | Bath, Hydro-massage |
| Applicant | BOUVIER HYDRO, INC. 100 WALNUT ST. SUITE 20 P.O. BOX 2874 Champlain,, NY 12919 |
| Contact | Joyce M Duquette |
| Correspondent | Joyce M Duquette BOUVIER HYDRO, INC. 100 WALNUT ST. SUITE 20 P.O. BOX 2874 Champlain,, NY 12919 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-10 |
| Decision Date | 1998-08-11 |