Device Classification Name |
electrocautery, gynecologic (and accessories)
|
510(k) Number |
K925560 |
Device Name |
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES |
Applicant |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
TRISH WILLGING |
Correspondent |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
TRISH WILLGING |
Regulation Number | 884.4120
|
Classification Product Code |
|
Date Received | 11/03/1992 |
Decision Date | 08/30/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|