The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for 27+ Ultravit Probe, 27+ Flex-tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula.
| Device ID | K110951 |
| 510k Number | K110951 |
| Device Name: | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA |
| Classification | Photocoagulator And Accessories |
| Applicant | ALCON RESEARCH, LTD. 15800 ALTON PARKWAY Irvine, CA 92618 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman ALCON RESEARCH, LTD. 15800 ALTON PARKWAY Irvine, CA 92618 |
| Product Code | HQB |
| Subsequent Product Code | HMX |
| Subsequent Product Code | HQE |
| Subsequent Product Code | NGY |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-10-17 |
| Summary: | summary |