K973633 is an FDA 510(k) clearance for the ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET. This device is classified as a Lacrimal Stents And Intubation Sets.
Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on January 16, 1998, 183 days after receiving the submission on July 17, 1997.
This device falls under the Ophthalmic FDA review panel. 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 An Infant..
| 510(k) Number | K973633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1997 |
| Decision Date | January 16, 1998 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OKS — Lacrimal Stents And Intubation Sets |
| Device Class | — |
| Definition | 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 An Infant. |