The following data is part of a premarket notification filed by Mend Technologies, Inc. with the FDA for Iop Adjustable Stirrup.
Device ID | K884558 |
510k Number | K884558 |
Device Name: | IOP ADJUSTABLE STIRRUP |
Classification | Table And Attachments, Operating-room |
Applicant | MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
Contact | T. H Parke |
Correspondent | T. H Parke MEND TECHNOLOGIES, INC. 5757 ALPHA RD. SUITE 304 Dallas, TX 75240 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-31 |
Decision Date | 1988-11-17 |