Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K923628 |
Device Name |
CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE |
Applicant |
BRUCE MCLUCAS |
1140 NINETEENTH STREET, N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
PETER O SADIR |
Correspondent |
BRUCE MCLUCAS |
1140 NINETEENTH STREET, N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
PETER O SADIR |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 07/21/1992 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|