Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K803086 |
Device Name |
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE |
Applicant |
CRAIG & CRAIG, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CRAIG & CRAIG, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 12/08/1980 |
Decision Date | 07/01/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|