MICROVISION SCLERAL BUCKLING COMPONENTS


Device Classification Name

implant, orbital, extra-ocular

510(k) Number K023481
Device Name MICROVISION SCLERAL BUCKLING COMPONENTS
Original Applicant
MICROVISION, INC.
49 plain st.
north attleboro, 
MA 
02760

Original Contact sheila hemeon-heyer, jd, rac
Regulation Number 886.3340
Classification Product Code
HQX  
Date Received 10/17/2002
Decision Date 01/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No