LUNEAU STERILE TONOMETER SEPARATION PRISMS


Device Classification Name

tonometer, manual

510(k) Number K023838
Device Name LUNEAU STERILE TONOMETER SEPARATION PRISMS
Original Applicant
LUNEAU SA
bp 252
chartres cedex, 

FR

28005

Original Contact jean n young
Regulation Number 886.1930
Classification Product Code
HKY  
Date Received 11/18/2002
Decision Date 02/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No