Device Classification Name |
Electrode, Circular (Spiral), Scalp And Applicator
|
510(k) Number |
K844608 |
Device Name |
SURGICRAFT COPELAND DISPOSABLE |
Applicant |
A.W. SHOWELL (SURGICRAFT) LTD. |
BRITTEN ST. |
REDDITCH |
WORCS. B97 6HF ENGLAND,
GB
|
|
Applicant Contact |
SHOWELL |
Correspondent |
A.W. SHOWELL (SURGICRAFT) LTD. |
BRITTEN ST. |
REDDITCH |
WORCS. B97 6HF ENGLAND,
GB
|
|
Correspondent Contact |
SHOWELL |
Regulation Number | 884.2675
|
Classification Product Code |
|
Date Received | 11/27/1984 |
Decision Date | 05/01/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|