The following data is part of a premarket notification filed by M.i. Tech Co., Ltd. with the FDA for Choostent.
Device ID | K072094 |
510k Number | K072094 |
Device Name: | CHOOSTENT |
Classification | Prosthesis, Esophageal |
Applicant | M.I. TECH CO., LTD. P.O. BOX 2007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm M.I. TECH CO., LTD. P.O. BOX 2007 Deerfield, IL 60015 |
Product Code | ESW |
CFR Regulation Number | 878.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-30 |
Decision Date | 2008-09-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CHOOSTENT 88410641 not registered Live/Pending |
M.I.Tech Co., Ltd. 2019-05-01 |
CHOOSTENT 79104205 not registered Dead/Abandoned |
M.I.Tech Co.,Inc 2009-09-22 |