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FDA 510(k)

RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06

K-Number: K081455 · 2008-09-05

ApplicantRayner Surgical, Inc.
Decision Date2008-09-05
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 is the device name listed in this FDA 510(k) record. The listed applicant is Rayner Surgical, Inc.. It received FDA 510(k) clearance on 2008-09-05 under 510(k) number K081455. 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 SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06?

RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 is a medical device that received FDA 510(k) clearance on 2008-09-05. The listed applicant is Rayner Surgical, Inc.. The 510(k) number is K081455.

When did RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 receive FDA 510(k) clearance?

RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 received FDA 510(k) clearance on 2008-09-05, under 510(k) number K081455.

Who is the listed applicant for RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06?

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

What is the FDA product code for RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06?

The FDA product code for RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 is MSS.

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Other records listing Rayner Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062612RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04K052651C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02

Related Devices (Code: MSS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261174RxSight® Insertion DeviceRxsight, Inc.K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.

Official Source

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