510(k) K072985
K072985 is an FDA 510(k) premarket notification submitted by Duckworth & Kent, Ltd. for the device "DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2". The FDA issued a decision of Substantially Equivalent on June 20, 2008. The device falls under product code KYB (Lens, Guide, Intraocular), 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
- June 20, 2008
- Date Received
- October 23, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Guide, Intraocular
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type