The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Enhanced Ultra Vit Probe.
| Device ID | K093305 |
| 510k Number | K093305 |
| Device Name: | ENHANCED ULTRA VIT PROBE |
| Classification | Vitrectomy, Instrument Cutter |
| 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 | MLZ |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-22 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380657524515 | K093305 | 000 |
| 10380657515711 | K093305 | 000 |
| 10380657509482 | K093305 | 000 |
| 10380657509499 | K093305 | 000 |
| 10380657509505 | K093305 | 000 |
| 10380657514387 | K093305 | 000 |
| 10380657524355 | K093305 | 000 |
| 10380657524362 | K093305 | 000 |
| 10380657524379 | K093305 | 000 |
| 10380657524386 | K093305 | 000 |
| 10380657524393 | K093305 | 000 |
| 10380657524492 | K093305 | 000 |
| 10380657524508 | K093305 | 000 |
| 10380657515704 | K093305 | 000 |