Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K853683 |
Device Name |
UMS-100 |
Applicant |
NARCO BIO-SYSTEMS |
7651 AIRPORT BLVD. |
HOUSTON,
TX
77061
|
|
Applicant Contact |
HARVEY KNAUSS |
Correspondent |
NARCO BIO-SYSTEMS |
7651 AIRPORT BLVD. |
HOUSTON,
TX
77061
|
|
Correspondent Contact |
HARVEY KNAUSS |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 09/04/1985 |
Decision Date | 01/10/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|