The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Lacrimal Stent.
Device ID | K812255 |
510k Number | K812255 |
Device Name: | ETHICON LACRIMAL STENT |
Classification | Probe, Lachrymal |
Applicant | ETHICON, INC. 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 | 1981-08-12 |
Decision Date | 1981-08-20 |