Device Classification Name |
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
|
510(k) Number |
K781089 |
Device Name |
ONE INCISION BI-POLAR ELECTRO. FORCEPS |
Applicant |
KLI |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KLI |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.4150
|
Classification Product Code |
|
Date Received | 06/29/1978 |
Decision Date | 07/17/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|