Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K070270 |
Device Name |
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 |
Applicant |
KIRCHNER & WILHELM GMBH + CO.KG |
55 NORTHERN BLVD, SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
NATALYA VALERIO |
Correspondent |
KIRCHNER & WILHELM GMBH + CO.KG |
55 NORTHERN BLVD, SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
NATALYA VALERIO |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 01/29/2007 |
Decision Date | 11/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|