510(k) K042478
K042478 is an FDA 510(k) premarket notification submitted by Duckworth & Kent, Ltd. for the device "CAPSULE TENSION RING INSERTER, MODEL 7-810". The FDA issued a decision of Substantially Equivalent on December 28, 2004. The device falls under product code NCE (Injector, Capsular Tension Ring), 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
- December 28, 2004
- Date Received
- September 13, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Capsular Tension Ring
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type