Device Classification Name |
Syringe, Piston
|
510(k) Number |
K014088 |
Device Name |
DUPLOREACH |
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 | 12/12/2001 |
Decision Date | 06/07/2002 |
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
|
|
|