Device Classification Name |
Resectoscope, Working Element
|
510(k) Number |
K895643 |
Device Name |
MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM |
Applicant |
ORTHOCONCEPT, INC. |
8 COLD BRANCH CT |
COLUMBIA,
SC
29223
|
|
Applicant Contact |
JACK DEFRANCO |
Correspondent |
ORTHOCONCEPT, INC. |
8 COLD BRANCH CT |
COLUMBIA,
SC
29223
|
|
Correspondent Contact |
JACK DEFRANCO |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/28/1989 |
Decision Date | 10/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|