Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K992198 |
Device Name |
URETHANE PICC LINE MODEL UPICS- |
Applicant |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
LISA WEBB |
Correspondent |
COOK, INC. |
925 SOUTH CURRY PIKE |
P.O. BOX 489 |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
LISA WEBB |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 06/30/1999 |
Decision Date | 08/27/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|