Device Classification Name |
Cap, Cervical
|
510(k) Number |
K881414 |
Device Name |
CERVICATH |
Applicant |
EPCOM MEDICAL SYSTEMS, INC. |
302 LINDBERGH AVE. |
LIVERMORE,
CA
94550
|
|
Applicant Contact |
PAUL ULBRICH |
Correspondent |
EPCOM MEDICAL SYSTEMS, INC. |
302 LINDBERGH AVE. |
LIVERMORE,
CA
94550
|
|
Correspondent Contact |
PAUL ULBRICH |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 04/04/1988 |
Decision Date | 06/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|