The following data is part of a premarket notification filed by Crospon Ltd. with the FDA for Endoflip.
Device ID | K160725 |
510k Number | K160725 |
Device Name: | EndoFLIP |
Classification | System, Gastrointestinal Motility (electrical) |
Applicant | CROSPON LTD. GALWAY BUSINESS PARK, DANGAN Galway, IE |
Contact | John O'dea |
Correspondent | Paul Dryden CROSPON LTD. GALWAY BUSINESS PARK, DANGAN Galway, IE |
Product Code | FFX |
CFR Regulation Number | 876.1725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-16 |
Decision Date | 2016-05-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05391530810166 | K160725 | 000 |
05391530810050 | K160725 | 000 |
05391530810005 | K160725 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOFLIP 77172827 4116590 Live/Registered |
FLIP TECHNOLOGIES LIMITED 2007-05-04 |