Atrion Medical Coated Lacrimal Intubation Set
FDA 510(k) K973872 · Atrion Medical Products, Inc.
510(k) numberK973872
Submission
- Device name
- Atrion Medical Coated Lacrimal Intubation Set
- Applicant
- Atrion Medical Products, Inc.
Arab, AL, US - Received
- October 10, 1997
- Decision date
- January 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OKS – Lacrimal Stents And Intubation Sets
- Device class
- Unclassified
- Implant
- Yes
Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in…
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Questions and answers
When was Atrion Medical Coated Lacrimal Intubation Set cleared by the FDA?
Atrion Medical Coated Lacrimal Intubation Set (K973872) received a 510(k) decision of Substantially Equivalent on January 8, 1998, 90 days after the submission was received.
What is the product code of K973872?
The FDA product code is OKS – Lacrimal Stents And Intubation Sets, a Unclassified device.