The following data is part of a premarket notification filed by Aaren Scientific, Inc with the FDA for Z Cartridge Iol Delivery System.
| Device ID | K123888 |
| 510k Number | K123888 |
| Device Name: | Z CARTRIDGE IOL DELIVERY SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | AAREN SCIENTIFIC, INC 4290 E. BRICKELL ST. BLDG A Ontario, CA 91761 |
| Contact | Robert K Sheehan |
| Correspondent | Robert K Sheehan AAREN SCIENTIFIC, INC 4290 E. BRICKELL ST. BLDG A Ontario, CA 91761 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843045101840 | K123888 | 000 |
| 00843045101833 | K123888 | 000 |