Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K002786 |
Device Name |
BIOSENSORS CENTRAL VENOUS CATHETER KITS |
Applicant |
SUNSCOPE INTL., INC. |
20250 ACACIA ST., SUITE 115 |
NEWPORT BEACH,
CA
92660
|
|
Applicant Contact |
JORGE HAIDER |
Correspondent |
SUNSCOPE INTL., INC. |
20250 ACACIA ST., SUITE 115 |
NEWPORT BEACH,
CA
92660
|
|
Correspondent Contact |
JORGE HAIDER |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/07/2000 |
Decision Date | 11/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|