The following data is part of a premarket notification filed by Visitec Co. with the FDA for Lacimal Intubation Sets.
| Device ID | K831901 |
| 510k Number | K831901 |
| Device Name: | LACIMAL INTUBATION SETS |
| Classification | Probe, Lachrymal |
| Applicant | VISITEC CO. 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 | 1983-06-14 |
| Decision Date | 1983-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886158101246 | K831901 | 000 |
| 00886158101239 | K831901 | 000 |
| 00886158101222 | K831901 | 000 |
| 00886158101215 | K831901 | 000 |