Device Classification Name |
Pelvic Exam Kit
|
510(k) Number |
K931822 |
Device Name |
CARAPACE PELVIC EXAM TRAYS |
Applicant |
CARAPACE, INC. |
2701 W CONCORD ST. |
BROKEN ARROW,
OK
74012
|
|
Applicant Contact |
JERRY W MEYERS |
Correspondent |
CARAPACE, INC. |
2701 W CONCORD ST. |
BROKEN ARROW,
OK
74012
|
|
Correspondent Contact |
JERRY W MEYERS |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 04/08/1993 |
Decision Date | 03/07/1994 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|