Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K972527 |
Device Name |
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS |
Applicant |
QUALITY SYSTEM CONSULTING |
1425 CRESSA COURT |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
FRED SCHLADOR |
Correspondent |
QUALITY SYSTEM CONSULTING |
1425 CRESSA COURT |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
FRED SCHLADOR |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/07/1997 |
Decision Date | 09/18/1997 |
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
|
|
|