The following data is part of a premarket notification filed by Labac Systems, Inc. with the FDA for Tilt Adjustable Sliding Back Recline Seating Syst.
Device ID | K923364 |
510k Number | K923364 |
Device Name: | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST |
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 | 1992-07-08 |
Decision Date | 1993-03-22 |