The following data is part of a premarket notification filed by Mcconnell Orthopedic with the FDA for Mcconnell Orthopedic Universal Positioner (mup).
Device ID | K871803 |
510k Number | K871803 |
Device Name: | MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP) |
Classification | Operating Room Accessories Table Tray |
Applicant | MCCONNELL ORTHOPEDIC GLASER, GRIGGS & SCHWARTZ 5430 LBJ FREEWAY, SUITE 1540 Dallas, TX 78240 |
Contact | Dennis T Griggs |
Correspondent | Dennis T Griggs MCCONNELL ORTHOPEDIC GLASER, GRIGGS & SCHWARTZ 5430 LBJ FREEWAY, SUITE 1540 Dallas, TX 78240 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-08 |
Decision Date | 1987-05-19 |