Device Classification Name |
introducer, catheter
|
510(k) Number |
K961135 |
Device Name |
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) |
Applicant |
C.R. BARD, INC. |
1200 TECHNOLOGY PARK DR. |
P.O. BOX 7025 |
BILLERICA,
MA
01821
|
|
Applicant Contact |
ROBERT T MIRAGLIUOLO |
Correspondent |
C.R. BARD, INC. |
1200 TECHNOLOGY PARK DR. |
P.O. BOX 7025 |
BILLERICA,
MA
01821
|
|
Correspondent Contact |
ROBERT T MIRAGLIUOLO |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/21/1996 |
Decision Date | 04/30/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|