The following data is part of a premarket notification filed by Labac Systems, Inc. with the FDA for Manual Tilt Recline Chair (mtc).
Device ID | K932639 |
510k Number | K932639 |
Device Name: | MANUAL TILT RECLINE CHAIR (MTC) |
Classification | Wheelchair, Mechanical |
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 | IOR |
CFR Regulation Number | 890.3850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-02 |
Decision Date | 1993-07-22 |