510(k) K024072
K024072 is an FDA 510(k) premarket notification submitted by Duckworth & Kent, Ltd. for the device "DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2003. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Duckworth & Kent, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2003
- Date Received
- December 10, 2002
- 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