Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K801871 |
Device Name |
PRIMARY SOLUTION ADMIN. SET-#86-01-0 260 |
Applicant |
Y |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
Y |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/05/1980 |
Decision Date | 08/27/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|