The following data is part of a premarket notification filed by Ljt Surgical Ltd with the FDA for Stoploss Jones Tube.
Device ID | K140290 |
510k Number | K140290 |
Device Name: | STOPLOSS JONES TUBE |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | LJT SURGICAL LTD 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
Contact | Patsy J Trisler, Jd, Rac |
Correspondent | Patsy J Trisler, Jd, Rac LJT SURGICAL LTD 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
Product Code | OKS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-05 |
Decision Date | 2014-12-02 |
Summary: | summary |