The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Wheelchairs.
Device ID | K844574 |
510k Number | K844574 |
Device Name: | WHEELCHAIRS |
Classification | Wheelchair, Mechanical |
Applicant | MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
Contact | James C Nicholas |
Correspondent | James C Nicholas MEDICON, INC. 143 NEW CANAAN AVE. Norwalk, CT 06850 |
Product Code | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-23 |
Decision Date | 1985-02-21 |