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 | K142914 |
| 510k Number | K142914 |
| Device Name: | DacryoCATH |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | ARMADILLO BIOMEDICAL, LLC 5363 Balbao Blvd., Suite 246 Encino, CA 91316 |
| Contact | Bruce Becker, M.d. |
| Correspondent | Greg Holland REGULATORY SPECIALISTS, INC. 3722 AVE SAUSALITO Irvine, CA 92606 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-07 |
| Decision Date | 2015-01-12 |
| Summary: | summary |
Trademark Results [DacryoCATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DACRYOCATH 85111789 4165145 Live/Registered |
Armadillo Biomedical LLC 2010-08-19 |
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