Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K801575 |
Device Name |
L-CATH INTRAVENOUS PLACEMENT UNIT |
Applicant |
LUTHER MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
LUTHER MEDICAL PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/08/1980 |
Decision Date | 08/20/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|