Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K002138 |
FOIA Releasable 510(k) |
K002138
|
Device Name |
PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 |
Applicant |
MAERSK MEDICAL A/S |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Applicant Contact |
JENNIFER LYONS |
Correspondent |
MAERSK MEDICAL A/S |
12744 SAN FERNANDO RD. |
SYLMAR,
CA
91342
|
|
Correspondent Contact |
JENNIFER LYONS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/17/2000 |
Decision Date | 08/29/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|