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FDA 510(k)

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18

K-Number: K091507 · 2009-12-04

ApplicantRayner Intraocular Lenses , Ltd.
Decision Date2009-12-04
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 is the device name listed in this FDA 510(k) record. The listed applicant is Rayner Intraocular Lenses , Ltd.. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K091507. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18?

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Rayner Intraocular Lenses , Ltd.. The 510(k) number is K091507.

When did RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 receive FDA 510(k) clearance?

RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 received FDA 510(k) clearance on 2009-12-04, under 510(k) number K091507.

Who is the listed applicant for RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18?

The FDA 510(k) record lists Rayner Intraocular Lenses , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18?

The FDA product code for RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 is MSS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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