Device Classification Name |
Ophthalmoscope, Battery-Powered
|
510(k) Number |
K932504 |
Device Name |
RI-FORMER |
Applicant |
RUDOLF RIESTER GMBH & CO. KG |
POSTFACH 35 |
BRUCKSTRABE 31 |
D-72417 JUNGINGEN,
DE
|
|
Applicant Contact |
KARLHEINZ RIESTER |
Correspondent |
RUDOLF RIESTER GMBH & CO. KG |
POSTFACH 35 |
BRUCKSTRABE 31 |
D-72417 JUNGINGEN,
DE
|
|
Correspondent Contact |
KARLHEINZ RIESTER |
Regulation Number | 886.1570 |
Classification Product Code |
|
Date Received | 05/21/1993 |
Decision Date | 10/15/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|