Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K761327 |
Device Name |
IV SETS 2000 SERIES (HS-200,2L0,220) |
Applicant |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/27/1976 |
Decision Date | 01/31/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|