510(k) K123888
K123888 is an FDA 510(k) premarket notification submitted by Aaren Scientific, Inc. for the device "Z CARTRIDGE IOL DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 15, 2013. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2013
- Date Received
- December 18, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Folders And Injectors, Intraocular Lens (Iol)
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type