Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K991653 |
Device Name |
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM |
Applicant |
RYMED TECHNOLOGIES, INC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Applicant Contact |
AL WEISENBORN |
Correspondent |
RYMED TECHNOLOGIES, INC. |
19526 EAST LAKE DR. |
MIAMI,
FL
33015
|
|
Correspondent Contact |
AL WEISENBORN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/13/1999 |
Decision Date | 06/24/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|