Device Classification Name |
Spatula, Cervical, Cytological
|
510(k) Number |
K891032 |
Device Name |
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG |
Applicant |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
ANNA STRAIGHT |
Correspondent |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
ANNA STRAIGHT |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 02/28/1989 |
Decision Date | 03/22/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|