The following data is part of a premarket notification filed by Dcs Surgical Inc with the FDA for Dcs Lacrimal Stent.
Device ID | K113316 |
510k Number | K113316 |
Device Name: | DCS LACRIMAL STENT |
Classification | Lacrimal Stents And Intubation Sets |
Applicant | DCS SURGICAL INC 1110 LINDEN AVE. Boulder, CO 80304 |
Contact | Harry Ross |
Correspondent | Harry Ross DCS SURGICAL INC 1110 LINDEN AVE. Boulder, CO 80304 |
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 | 2011-11-09 |
Decision Date | 2012-11-08 |
Summary: | summary |