The following data is part of a premarket notification filed by Medi-man Rehabilitation Products, Inc. with the FDA for A-2000 Bathing Systems; Hydrosonic Bathin System.
Device ID | K992779 |
510k Number | K992779 |
Device Name: | A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM |
Classification | Bath, Hydro-massage |
Applicant | MEDI-MAN REHABILITATION PRODUCTS, INC. 6200 TOMKEN ROAD Mississauga, Ontario, CA L5t 1x7 |
Contact | John T Mogensen |
Correspondent | John T Mogensen MEDI-MAN REHABILITATION PRODUCTS, INC. 6200 TOMKEN ROAD Mississauga, Ontario, CA L5t 1x7 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-18 |
Decision Date | 2000-01-13 |