Device Classification Name |
pacemaker lead adaptor
|
510(k) Number |
K781626 |
Device Name |
PACING LEAD ADAPTER, ACV 14, ACV 23 |
Applicant |
R.E. BROWN CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
R.E. BROWN CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.3620
|
Classification Product Code |
|
Date Received | 09/20/1978 |
Decision Date | 12/08/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|