Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K903364 |
Device Name |
GERARD MEDICAL, INC. TRIM-PORT |
Applicant |
GERARD MEDICAL ENTERPRISES, INC. |
P.O. BOX 348 |
BRIMFIELD,
MA
01010
|
|
Applicant Contact |
CAYER, JR. |
Correspondent |
GERARD MEDICAL ENTERPRISES, INC. |
P.O. BOX 348 |
BRIMFIELD,
MA
01010
|
|
Correspondent Contact |
CAYER, JR. |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 07/26/1990 |
Decision Date | 10/31/1990 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|