Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K990308 |
Device Name |
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML |
Applicant |
ROCAP DIV. OF SABRATEK CORP. |
1629 PRIME COURT |
BUILDING 100 |
ORLANDO,
FL
32809
|
|
Applicant Contact |
AVIA TONEY |
Correspondent |
ROCAP DIV. OF SABRATEK CORP. |
1629 PRIME COURT |
BUILDING 100 |
ORLANDO,
FL
32809
|
|
Correspondent Contact |
AVIA TONEY |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/01/1999 |
Decision Date | 12/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|