The following data is part of a premarket notification filed by Mcconnell Orthopedic with the FDA for Prep And Operating Stand.
Device ID | K905564 |
510k Number | K905564 |
Device Name: | PREP AND OPERATING STAND |
Classification | Operating Room Accessories Table Tray |
Applicant | MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
Contact | Dennis T Griggs |
Correspondent | Dennis T Griggs MCCONNELL ORTHOPEDIC TREEE LINCOLN CENTRE 5430 LBJ FREEWAY SUITE 1540 Dallas, TX 75240 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-12 |
Decision Date | 1991-02-21 |