The following data is part of a premarket notification filed by Flexmedics with the FDA for Straight Length Arch Wires.
Device ID | K881233 |
510k Number | K881233 |
Device Name: | STRAIGHT LENGTH ARCH WIRES |
Classification | Bracket, Metal, Orthodontic |
Applicant | FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
Contact | Sievert, Jr. |
Correspondent | Sievert, Jr. FLEXMEDICS 620 FORD CTR., 420 N. FIFTH STREET Minneapolis, MN 55401 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-22 |
Decision Date | 1988-04-12 |