Device Classification Name |
electrocautery, gynecologic (and accessories)
|
510(k) Number |
K974138 |
Device Name |
ROCKET ELECTRODE |
Applicant |
A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B |
ALPHARETTA,
GA
30201
|
|
Applicant Contact |
JIHAD MANSOUR |
Correspondent |
A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B |
ALPHARETTA,
GA
30201
|
|
Correspondent Contact |
JIHAD MANSOUR |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 11/03/1997 |
Decision Date | 01/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|