The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Fiber Optic Canaliculus Intuba.
| Device ID | K843491 |
| 510k Number | K843491 |
| Device Name: | CONCEPT FIBER OPTIC CANALICULUS INTUBA |
| Classification | Probe, Lachrymal |
| Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Contact | Unknown Unknown |
| Correspondent | Unknown Unknown CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
| Product Code | HNL |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-10-05 |