Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K942623 |
Device Name |
TRIMPORT |
Applicant |
GERARD MEDICAL ENTERPRISES, INC. |
90 WORCESTER RD. |
UNIT 2, BOX 6 |
CHARLTON,
MA
01507
|
|
Applicant Contact |
RICHARD CAYER JR. |
Correspondent |
GERARD MEDICAL ENTERPRISES, INC. |
90 WORCESTER RD. |
UNIT 2, BOX 6 |
CHARLTON,
MA
01507
|
|
Correspondent Contact |
RICHARD CAYER JR. |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 05/27/1994 |
Decision Date | 08/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|