Device Classification Name |
Transducer, Ultrasonic, Obstetric
|
510(k) Number |
K863797 |
Device Name |
BIOPSY NEEDLE GUIDE ATTACHMENT |
Applicant |
ELSCINT, INC. |
751 EXPRESSWAY DR. |
ITASCA,
IL
60143
|
|
Applicant Contact |
ROBERT E KENNEY |
Correspondent |
ELSCINT, INC. |
751 EXPRESSWAY DR. |
ITASCA,
IL
60143
|
|
Correspondent Contact |
ROBERT E KENNEY |
Regulation Number | 884.2960
|
Classification Product Code |
|
Date Received | 09/29/1986 |
Decision Date | 03/27/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|