The following data is part of a premarket notification filed by Synexmed (shenzhen) Company Limited with the FDA for Im Band.
Device ID | K113600 |
510k Number | K113600 |
Device Name: | IM BAND |
Classification | Clamp, Vascular |
Applicant | SYNEXMED (SHENZHEN) COMPANY LIMITED B-11/F,ZTY Buliding,TaoHuaRd, Futian Free Trade Zone,ShenZhe Shenzhen, Guangdong, CN 518038 |
Contact | Eric Chien |
Correspondent | Eric Chien SYNEXMED (SHENZHEN) COMPANY LIMITED B-11/F,ZTY Buliding,TaoHuaRd, Futian Free Trade Zone,ShenZhe Shenzhen, Guangdong, CN 518038 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-05 |
Decision Date | 2012-02-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IM BAND 75743981 2507724 Dead/Cancelled |
SonicBox, Inc. 1999-07-06 |