Device Classification Name |
set, blood transfusion
|
510(k) Number |
K050805 |
Device Name |
30 ML OR 60 ML PEDI-SYRINGE FILTER |
Applicant |
BLOOD PRODUCTS SPECIALTIES LLC |
184 SEIFFERT COURT |
OCEANSIDE,
NY
11572
|
|
Applicant Contact |
ALAN A WALDMAN |
Correspondent |
BLOOD PRODUCTS SPECIALTIES LLC |
184 SEIFFERT COURT |
OCEANSIDE,
NY
11572
|
|
Correspondent Contact |
ALAN A WALDMAN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2005 |
Decision Date | 06/20/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|