Device Classification Name |
electrocautery, gynecologic (and accessories)
|
510(k) Number |
K983840 |
Device Name |
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) |
Applicant |
WALLACH SURGICAL DEVICES, INC. |
235 EDISON RD. |
ORANGE,
CT
06477
|
|
Applicant Contact |
MICHAEL MALIS |
Correspondent |
WALLACH SURGICAL DEVICES, INC. |
235 EDISON RD. |
ORANGE,
CT
06477
|
|
Correspondent Contact |
MICHAEL MALIS |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 10/30/1998 |
Decision Date | 05/20/1999 |
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
|
|
|