The following data is part of a premarket notification filed by Feet For Life Podiatry Center with the FDA for Easy Out.
Device ID | K141401 |
510k Number | K141401 |
Device Name: | EASY OUT |
Classification | Screw, Fixation, Bone |
Applicant | FEET FOR LIFE PODIATRY CENTER 8637 DELMAR BLVD. Saint Louis, MO 63124 |
Contact | Michael Horwitz |
Correspondent | Carrie Hetrick EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austn, TX 78701 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-28 |
Decision Date | 2015-02-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853785008040 | K141401 | 000 |
00853785008033 | K141401 | 000 |
00853785008026 | K141401 | 000 |
00853785008019 | K141401 | 000 |
00853785008002 | K141401 | 000 |