The following data is part of a premarket notification filed by Ward And Assoc. with the FDA for Alden Wheelchair Cushion.
Device ID | K942260 |
510k Number | K942260 |
Device Name: | ALDEN WHEELCHAIR CUSHION |
Classification | Components, Wheelchair |
Applicant | WARD AND ASSOC. 4655 KIRKWOOD CT. BOULDER, CO 80301 |
Contact | LEWIS WARD |
Correspondent | LEWIS WARD WARD AND ASSOC. 4655 KIRKWOOD CT. BOULDER, CO 80301 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-09 |
Decision Date | 1994-05-26 |