DACRYOCATH
Lacrimal Stents And Intubation Sets
ARMADILLO BIOMEDICAL, LLC
The following data is part of a premarket notification filed by Armadillo Biomedical, Llc with the FDA for Dacryocath.
Pre-market Notification Details
| Device ID | K113508 |
| 510k Number | K113508 |
| Device Name: | DACRYOCATH |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | ARMADILLO BIOMEDICAL, LLC 3722 AVE SAUSALITO Irvine, CA 92606 |
| Contact | Robyn Scopis |
| Correspondent | Robyn Scopis ARMADILLO BIOMEDICAL, LLC 3722 AVE SAUSALITO Irvine, CA 92606 |
| 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 | 2011-11-28 |
| Decision Date | 2012-08-31 |
| Summary: | summary |
Trademark Results [DACRYOCATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DACRYOCATH 85111789 4165145 Live/Registered |
Armadillo Biomedical LLC 2010-08-19 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.