The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Arthrotract Upper Limb Traction Accessory.
Device ID | K874762 |
510k Number | K874762 |
Device Name: | ARTHROTRACT UPPER LIMB TRACTION ACCESSORY |
Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
Applicant | ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
Contact | Macneil P.eng |
Correspondent | Macneil P.eng ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
Product Code | JEA |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-19 |
Decision Date | 1987-12-10 |