FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
CAPSULE TENSION RING INSERTER, MODEL 7-810
K Number: K042478
·
Decision Dec 28, 2004
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
6
Review Days
106
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Basic Information
- Device Name
- CAPSULE TENSION RING INSERTER, MODEL 7-810
- K Number
- K042478
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Duckworth & Kent, Ltd.
- Date Received
- September 13, 2004
- Decision Date
- December 28, 2004
- Product Code
- NCE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NCE | Injector, Capsular Tension Ring | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NCE), ordered by most recent decision date.
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GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
FDA 510(k)
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Other Clearances by Duckworth & Kent, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | Oct 23, 2008 | Substantially Equivalent |
| K072985 | DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 | Jun 20, 2008 | Substantially Equivalent |
| K060995 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 | May 22, 2006 | Substantially Equivalent |
| K053176 | DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 | Jan 30, 2006 | Substantially Equivalent |
| K024072 | DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM | Oct 6, 2003 | Substantially Equivalent |