The following data is part of a premarket notification filed by Crospon, Ltd. with the FDA for Endoflip.
Device ID | K092850 |
510k Number | K092850 |
Device Name: | ENDOFLIP |
Classification | System, Gastrointestinal Motility (electrical) |
Applicant | CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
Contact | Paul Dryden |
Correspondent | Paul Dryden CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
Product Code | FFX |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-16 |
Decision Date | 2009-12-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |