Device Classification Name |
Electrocautery, Gynecologic (And Accessories)
|
510(k) Number |
K921791 |
Device Name |
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM |
Applicant |
WALLACH SURGICAL DEVICES, INC. |
291 PEPE'S FARM RD. |
MILFORD,
CT
06460
|
|
Applicant Contact |
VINCENT FRAZZETTA |
Correspondent |
WALLACH SURGICAL DEVICES, INC. |
291 PEPE'S FARM RD. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
VINCENT FRAZZETTA |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 04/14/1992 |
Decision Date | 05/04/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|