The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Arm Through For Wheelchair Bk-6458-01.
Device ID | K823637 |
510k Number | K823637 |
Device Name: | ARM THROUGH FOR WHEELCHAIR BK-6458-01 |
Classification | Components, Wheelchair |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-06 |
Decision Date | 1983-01-21 |