The following data is part of a premarket notification filed by Laura Cattabriga with the FDA for Bone Fragment And Fixation Plates, Screws And Washers.
Device ID | K130614 |
510k Number | K130614 |
Device Name: | BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS |
Classification | Plate, Fixation, Bone |
Applicant | LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village, FL 33141 |
Contact | Laura Cattabriga |
Correspondent | Laura Cattabriga LAURA CATTABRIGA 7430 CENTER BAY DRIVE N. Bay Village, FL 33141 |
Product Code | HRS |
Subsequent Product Code | HTN |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-07 |
Decision Date | 2014-01-17 |
Summary: | summary |