The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Laminar Flow Phaco Tips And Irrigation Sleeve (21g, Reusable).
| Device ID | K121721 |
| 510k Number | K121721 |
| Device Name: | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) |
| Classification | Unit, Phacofragmentation |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Abbas M Bohra |
| Correspondent | Abbas M Bohra ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-12 |
| Decision Date | 2012-10-15 |
| Summary: | summary |