The following data is part of a premarket notification filed by Genossis, Llc with the FDA for Optossol Compression Device System.
Device ID | K140875 |
510k Number | K140875 |
Device Name: | OPTOSSOL COMPRESSION DEVICE SYSTEM |
Classification | Pin, Fixation, Threaded |
Applicant | GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport, MA 01950 |
Contact | Barry E Sands |
Correspondent | Barry E Sands GENOSSIS, LLC 29 WATER STREET, SUITE 305 Newburyport, MA 01950 |
Product Code | JDW |
Subsequent Product Code | HTN |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-04 |
Decision Date | 2014-05-30 |
Summary: | summary |