Device Classification Name |
pump, infusion, elastomeric
|
510(k) Number |
K983454 |
FOIA Releasable 510(k) |
K983454
|
Device Name |
PAIN CARE 2000 |
Applicant |
BREG, INC. |
2611 COMMERCE WAY |
VISTA,
CA
92083
|
|
Applicant Contact |
KATHLEEN BARBER |
Correspondent |
BREG, INC. |
2611 COMMERCE WAY |
VISTA,
CA
92083
|
|
Correspondent Contact |
KATHLEEN BARBER |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/30/1998 |
Decision Date | 12/16/1998 |
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
|
|
|