Device Classification Name |
syringe, piston
|
510(k) Number |
K020666 |
Device Name |
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML |
Applicant |
BAXTER HEALTHCARE CORP. |
550 N. BRAND BLVD. |
GLENDALE,
CA
91203 -1900
|
|
Applicant Contact |
ARLENE VIDOR |
Correspondent |
BAXTER HEALTHCARE CORP. |
550 N. BRAND BLVD. |
GLENDALE,
CA
91203 -1900
|
|
Correspondent Contact |
ARLENE VIDOR |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 03/01/2002 |
Decision Date | 06/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|