The following data is part of a premarket notification filed by M.c. Healthcare Products, Inc. with the FDA for Benefit B3--- Series.
Device ID | K974254 |
510k Number | K974254 |
Device Name: | BENEFIT B3--- SERIES |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | M.C. HEALTHCARE PRODUCTS, INC. 4658 ONTARIO ST. Beamsville, Ontario, CA L0r 1b4 |
Contact | R N Thompson |
Correspondent | R N Thompson M.C. HEALTHCARE PRODUCTS, INC. 4658 ONTARIO ST. Beamsville, Ontario, CA L0r 1b4 |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-13 |
Decision Date | 1997-12-16 |