Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K993527 |
Device Name |
LOOP ELECTRODE, BALL ELECTRODE |
Applicant |
PALM MEDICAL USA, INC. |
6322 N.W. 18TH DR., SUITE 170 |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
MARK J KAHN |
Correspondent |
PALM MEDICAL USA, INC. |
6322 N.W. 18TH DR., SUITE 170 |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
MARK J KAHN |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 10/18/1999 |
Decision Date | 07/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|