Device Classification Name |
Needle, Aspiration And Injection, Reusable
|
510(k) Number |
K953082 |
Device Name |
ILIAC CREST BONE MARROW ASPIRATION NEEDLE |
Applicant |
BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. |
BLDG. K |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
SHARON RICHTER |
Correspondent |
BAXTER HEALTHCARE CORP. |
1500 WAUKEGAN RD. |
BLDG. K |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
SHARON RICHTER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/03/1995 |
Decision Date | 09/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|