Device Classification Name |
Catheter, Infusion
|
510(k) Number |
K813606 |
Device Name |
SILICONE ELASTOMER INFUSION CATHETER |
Applicant |
QUEST MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
QUEST MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 12/29/1981 |
Decision Date | 01/18/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|