The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Irrigation/aspiration Needle.
| Device ID | K771416 |
| 510k Number | K771416 |
| Device Name: | IRRIGATION/ASPIRATION NEEDLE |
| Classification | Cannula, Ophthalmic |
| Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-08-01 |
| Decision Date | 1977-09-12 |