Device Classification Name |
Otoscope
|
510(k) Number |
K925759 |
Device Name |
UNI I |
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 | 874.4770
|
Classification Product Code |
|
Date Received | 11/13/1992 |
Decision Date | 07/26/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|