The following data is part of a premarket notification filed by Easylap Ltd. with the FDA for Imesh Tacker.
Device ID | K110728 |
510k Number | K110728 |
Device Name: | IMESH TACKER |
Classification | Staple, Implantable |
Applicant | EASYLAP LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
Contact | Paul Dryden |
Correspondent | Paul Dryden EASYLAP LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-16 |
Decision Date | 2011-06-08 |
Summary: | summary |