The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Centurion Vision System (active Sentrytm).
| Device ID | K161794 |
| 510k Number | K161794 |
| Device Name: | CENTURION Vision System (Active SentryTM) |
| Classification | Unit, Phacofragmentation |
| Applicant | Alcon Research, Ltd. 6201 SOUTH FREEWAY DR. Fort Worth, TX 76134 -2099 |
| Contact | Paul Swift |
| Correspondent | Paul Swift Alcon Research, Ltd. 6201 SOUTH FREEWAY DR. Fort Worth, TX 76134 -2099 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-30 |
| Decision Date | 2017-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380657529148 | K161794 | 000 |