Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K922147 |
Device Name |
DUAL PLASTIC VASCULAR ACCESS SYSTEM |
Applicant |
GERARD MEDICAL ENTERPRISES, INC. |
90 WORCESTER RD. |
UNIT 2, BOX 6 |
CHARLTON,
MA
01507
|
|
Applicant Contact |
CAYER, JR. |
Correspondent |
GERARD MEDICAL ENTERPRISES, INC. |
90 WORCESTER RD. |
UNIT 2, BOX 6 |
CHARLTON,
MA
01507
|
|
Correspondent Contact |
CAYER, JR. |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 05/07/1992 |
Decision Date | 12/04/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|