Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K896561 |
Device Name |
EXTENSION SET |
Applicant |
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
1253 RAMONA ST. S.E. |
GRAND RAPIDS,
MI
49507
|
|
Applicant Contact |
SURY SHONEY |
Correspondent |
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
1253 RAMONA ST. S.E. |
GRAND RAPIDS,
MI
49507
|
|
Correspondent Contact |
SURY SHONEY |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/17/1989 |
Decision Date | 02/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|