The following data is part of a premarket notification filed by Hurricane Medical with the FDA for Lacrimal Intubation Set, Dacryocystorhinostomy (dcr) Set.
| Device ID | K990672 |
| 510k Number | K990672 |
| Device Name: | LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| Contact | David A Clapp |
| Correspondent | David A Clapp HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| 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 | 1999-03-02 |
| Decision Date | 1999-05-18 |
| Summary: | summary |