MERILAS 532A


Device Classification Name

laser, ophthalmic

510(k) Number K072823
Device Name MERILAS 532A
Applicant
MERIDIAN AG
13 red fox ln.
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
MERIDIAN AG
13 red fox ln.
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 10/02/2007
Decision Date 12/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No