Device Classification Name |
Tubing, Fluid Delivery
|
510(k) Number |
K941214 |
Device Name |
LIFESHIELD EXTENSION SET |
Applicant |
ABBOTT MFG., INC. |
ONE ABBOTT PARK |
ABBOTT PARK,
IL
60064
|
|
Applicant Contact |
FREDERICK A GUSTAFSON |
Correspondent |
ABBOTT MFG., INC. |
ONE ABBOTT PARK |
ABBOTT PARK,
IL
60064
|
|
Correspondent Contact |
FREDERICK A GUSTAFSON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/10/1994 |
Decision Date | 10/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|