RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
FDA 510(k) clearance K091507 · decided 2009-12-04
Clearance details
- K-number
- K091507
- Device name
- RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
- Applicant
- Rayner Intraocular Lenses , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-21
- Decision date
- 2009-12-04
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- MSS
- Device class
- 1
- Regulation number
- 886.4300
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Hove, East Sussex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.