LUNEAU 3 MIRROR LENS


Device Classification Name

lens, contact, polymethylmethacrylate, diagnostic

510(k) Number K022413
Device Name LUNEAU 3 MIRROR LENS
Original Applicant
LUNEAU SA
bp 252
chartres cedex, 

FR

28005

Original Contact jean noel young
Regulation Number 886.1385
Classification Product Code
HJK  
Date Received 07/24/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No