The following data is part of a premarket notification filed by Equipement Biomedical Specialise, Inc. with the FDA for Remusk Mp.
Device ID | K922029 |
510k Number | K922029 |
Device Name: | REMUSK MP |
Classification | Dynamometer, Ac-powered |
Applicant | EQUIPEMENT BIOMEDICAL SPECIALISE, INC. 2155 GUY ST. #820, MONTREAL Canada, CA H3h 2r9 |
Contact | Sylvain Boucher |
Correspondent | Sylvain Boucher EQUIPEMENT BIOMEDICAL SPECIALISE, INC. 2155 GUY ST. #820, MONTREAL Canada, CA H3h 2r9 |
Product Code | LBB |
CFR Regulation Number | 888.1240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-01 |
Decision Date | 1992-10-06 |