Device Classification Name |
instrument, manual, specialized obstetric-gynecologic
|
510(k) Number |
K864623 |
Device Name |
OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT |
Applicant |
XANMED CORP. |
85V. HOFFMAN LN. |
CENTRAL ISLIP,
NY
11722
|
|
Applicant Contact |
PATRICIA CLANCY |
Correspondent |
XANMED CORP. |
85V. HOFFMAN LN. |
CENTRAL ISLIP,
NY
11722
|
|
Correspondent Contact |
PATRICIA CLANCY |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 11/25/1986 |
Decision Date | 01/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|