The following data is part of a premarket notification filed by Labac Systems, Inc. with the FDA for Manual Chair Base.
Device ID | K921027 |
510k Number | K921027 |
Device Name: | MANUAL CHAIR BASE |
Classification | Components, Wheelchair |
Applicant | LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch, CO 80126 |
Contact | Peter Zeeb |
Correspondent | Peter Zeeb LABAC SYSTEMS, INC. 8955 SOUTH RIDGELINE BOULEVARD Highlands Ranch, CO 80126 |
Product Code | KNN |
CFR Regulation Number | 890.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-03 |
Decision Date | 1992-03-20 |