The following data is part of a premarket notification filed by Rayner Surgical Inc with the FDA for Rayner Single Use Small Incision Disposable Injector, Model R-inj-06.
Device ID | K081455 |
510k Number | K081455 |
Device Name: | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex, GB Bn3 7an |
Contact | Andrew Wells |
Correspondent | Andrew Wells RAYNER SURGICAL INC SACKVILLE ROAD Hove, East Sussex, GB Bn3 7an |
Product Code | MSS |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-23 |
Decision Date | 2008-09-05 |
Summary: | summary |