A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM

Bath, Hydro-massage

MEDI-MAN REHABILITATION PRODUCTS, INC.

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.

Pre-market Notification Details

Device IDK992779
510k NumberK992779
Device Name:A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
ClassificationBath, Hydro-massage
Applicant MEDI-MAN REHABILITATION PRODUCTS, INC. 6200 TOMKEN ROAD Mississauga, Ontario,  CA L5t 1x7
ContactJohn T Mogensen
CorrespondentJohn T Mogensen
MEDI-MAN REHABILITATION PRODUCTS, INC. 6200 TOMKEN ROAD Mississauga, Ontario,  CA L5t 1x7
Product CodeILJ  
CFR Regulation Number890.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-18
Decision Date2000-01-13

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