Device Classification Name |
Syringe, Balloon Inflation
|
510(k) Number |
K042449 |
Device Name |
DOLPHIN INFLATION DEVICE |
Applicant |
SEDAT S.A. |
45900 PARSIPPANY COURT |
TEMECULA,
CA
92592
|
|
Applicant Contact |
LAETITIA BERNARD |
Correspondent |
SEDAT S.A. |
45900 PARSIPPANY COURT |
TEMECULA,
CA
92592
|
|
Correspondent Contact |
LAETITIA BERNARD |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 09/09/2004 |
Decision Date | 04/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|