OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER


Device Classification Name

device,analysis,anterior segment

510(k) Number K030393
Device Name OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
Applicant
HAAG-STREIT HOLDING AG
7361 calhoun place, suite 500
rockville, 
MD 
20855 -2465

Applicant Contact eduardo march
Correspondent
HAAG-STREIT HOLDING AG
7361 calhoun place, suite 500
rockville, 
MD 
20855 -2465

Correspodent Contact eduardo march
Regulation Number 886.1850
Classification Product Code
MXK  
Date Received 02/05/2003
Decision Date 09/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No