Device Classification Name |
Monitor, Pressure, Intrauterine
|
510(k) Number |
K982565 |
Device Name |
EASY TRANS TIP |
Applicant |
CARL SCHUH |
10915 LURLINE AVE. |
CHATSOWRTH,
CA
91311 -1638
|
|
Applicant Contact |
CARL SCHUH |
Correspondent |
CARL SCHUH |
10915 LURLINE AVE. |
CHATSOWRTH,
CA
91311 -1638
|
|
Correspondent Contact |
CARL SCHUH |
Regulation Number | 884.2700
|
Classification Product Code |
|
Date Received | 07/23/1998 |
Decision Date | 09/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|