The following data is part of a premarket notification filed by Althan, Inc. with the FDA for Memory Wire.
Device ID | K923372 |
510k Number | K923372 |
Device Name: | MEMORY WIRE |
Classification | Bracket, Metal, Orthodontic |
Applicant | ALTHAN, INC. 115 CARTHAGE AVE. Cincinnati, OH 45215 |
Contact | Michael E Mechley |
Correspondent | Michael E Mechley ALTHAN, INC. 115 CARTHAGE AVE. Cincinnati, OH 45215 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-09 |
Decision Date | 1994-04-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MEMORY WIRE 85518485 not registered Dead/Abandoned |
Physician Endorsed 2012-01-17 |
![]() MEMORY WIRE 78003632 2482512 Dead/Cancelled |
ADRIAN, ANDREAS R. 2000-04-11 |
![]() MEMORY WIRE 73628704 1452266 Dead/Cancelled |
WACOAL AMERICA, INC. 1986-11-04 |