Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K973220 |
Device Name |
RODENSTOCK LASER SLITLAMP |
Applicant |
G. RODENSTOCK INSTRUMENTE GMBH |
100 MAIN ST. SUITE 120 |
CONCORD,
MA
|
|
Applicant Contact |
DAVID M LINK |
Correspondent |
G. RODENSTOCK INSTRUMENTE GMBH |
100 MAIN ST. SUITE 120 |
CONCORD,
MA
|
|
Correspondent Contact |
DAVID M LINK |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 08/27/1997 |
Decision Date | 11/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|