Device Classification Name |
Protector, Transducer, Dialysis
|
510(k) Number |
K851734 |
Device Name |
OMNIMED SUPERIOR TRANSDUCER PROTECTOR |
Applicant |
OMNI INTL., INC. |
870 RESEARCH DR. |
UNIT 5 |
PALM SPRINGS,
CA
92263
|
|
Applicant Contact |
RAMAN KADEVARI |
Correspondent |
OMNI INTL., INC. |
870 RESEARCH DR. |
UNIT 5 |
PALM SPRINGS,
CA
92263
|
|
Correspondent Contact |
RAMAN KADEVARI |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/25/1985 |
Decision Date | 05/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|