Device Classification Name |
introducer, catheter
|
510(k) Number |
K942977 |
Device Name |
NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE |
Applicant |
NOVOSTE CORP. |
4350-C INTERNATIONAL BLVD. |
SUITE C |
NORCROSS,
GA
30093 -3027
|
|
Applicant Contact |
JOAN M MACDONALD |
Correspondent |
NOVOSTE CORP. |
4350-C INTERNATIONAL BLVD. |
SUITE C |
NORCROSS,
GA
30093 -3027
|
|
Correspondent Contact |
JOAN M MACDONALD |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/20/1994 |
Decision Date | 12/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|