Device Classification Name |
System, Irrigation, Urological
|
510(k) Number |
K882295 |
Device Name |
FILLING VOLUME OPTION |
Applicant |
ERIS MEDICAL TECHNOLOGY |
1308 SPRINGFIELD AVE. |
NEW PROVIDENCE,
NJ
07974
|
|
Applicant Contact |
DAVID SUGGS |
Correspondent |
ERIS MEDICAL TECHNOLOGY |
1308 SPRINGFIELD AVE. |
NEW PROVIDENCE,
NJ
07974
|
|
Correspondent Contact |
DAVID SUGGS |
Regulation Number | 876.5130 |
Classification Product Code |
|
Date Received | 06/02/1988 |
Decision Date | 09/13/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|