Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K830755 |
Device Name |
I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- |
Applicant |
MEDICAL PARAMETERS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDICAL PARAMETERS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/10/1983 |
Decision Date | 04/28/1983 |
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
|
|
|