Device Classification Name |
ureteroscope and accessories, flexible/rigid
|
510(k) Number |
K920750 |
Device Name |
BARD URETEROSCOPE DEFLECTION MODULE |
Applicant |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Applicant Contact |
DONNA J WILSON |
Correspondent |
C.R. BARD, INC. |
8195 INDUSTRIAL BLVD. |
COVINGTON,
GA
30014
|
|
Correspondent Contact |
DONNA J WILSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/19/1992 |
Decision Date | 04/16/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|