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


Device Classification Name

folders and injectors, intraocular lens (iol)

510(k) Number K081455
Device Name RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
Applicant
RAYNER SURGICAL INC
sackville road
hove, east sussex, 

GB

bn3 7an

Applicant Contact andrew wells
Correspondent
RAYNER SURGICAL INC
sackville road
hove, east sussex, 

GB

bn3 7an

Correspodent Contact andrew wells
Regulation Number 886.4300
Classification Product Code
MSS  
Date Received 05/23/2008
Decision Date 09/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No