The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Crystalsert Crystalens Delivery System.
| Device ID | K082944 |
| 510k Number | K082944 |
| Device Name: | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | David Thomas |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-02 |
| Decision Date | 2008-10-16 |
| Summary: | summary |