Device Classification Name |
sterilant, medical devices
|
510(k) Number |
K932740 |
Device Name |
HOMEPUMP NSF |
Applicant |
BLOCK MEDICAL, INC. |
5957 LANDAU COURT |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
IAN KENNEDY |
Correspondent |
BLOCK MEDICAL, INC. |
5957 LANDAU COURT |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
IAN KENNEDY |
Regulation Number | 880.6885
|
Classification Product Code |
|
Date Received | 06/08/1993 |
Decision Date | 10/06/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|