Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K001386 |
Device Name |
ACCUSET SENSOR, MODEL 2000 |
Applicant |
PELVICARE, INC. |
28202 CABOT RD., SUITE 300 |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
WALTER D WALLACH |
Correspondent |
PELVICARE, INC. |
28202 CABOT RD., SUITE 300 |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
WALTER D WALLACH |
Regulation Number | 876.1620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/02/2000 |
Decision Date | 07/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|