The following data is part of a premarket notification filed by Mend Technologies, Inc. with the FDA for Mend Apc.
Device ID | K924094 |
510k Number | K924094 |
Device Name: | MEND APC |
Classification | Table, Surgical With Orthopedic Accessories, Ac-powered |
Applicant | MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
Contact | Parke |
Correspondent | Parke MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
Product Code | JEA |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-13 |
Decision Date | 1993-03-30 |