Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K910546 |
Device Name |
PIGGY LOCK NEEDLE HOUSING |
Applicant |
ICU MEDICAL, INC. |
142 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Applicant Contact |
ARACELI C FANCHER |
Correspondent |
ICU MEDICAL, INC. |
142 TECHNOLOGY DR. |
IRVINE,
CA
92718
|
|
Correspondent Contact |
ARACELI C FANCHER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/06/1991 |
Decision Date | 04/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|