Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K915841 |
Device Name |
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
ROWLAND WILLIAMS |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
ROWLAND WILLIAMS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/24/1991 |
Decision Date | 06/25/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|