510(k) K053176
K053176 is an FDA 510(k) premarket notification submitted by Duckworth & Kent, Ltd. for the device "DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797". The FDA issued a decision of Substantially Equivalent on January 30, 2006. 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
- January 30, 2006
- Date Received
- November 14, 2005
- 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