The following data is part of a premarket notification filed by Narco Scientific with the FDA for Pilling Lacrimal Intubation System.
Device ID | K813187 |
510k Number | K813187 |
Device Name: | PILLING LACRIMAL INTUBATION SYSTEM |
Classification | Probe, Lachrymal |
Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNL |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-16 |
Decision Date | 1982-01-28 |