Device Classification Name |
Amniotome
|
510(k) Number |
K910518 |
Device Name |
GLOVE-N-GEL AMNIOTOMY KIT |
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 | 884.4530
|
Classification Product Code |
|
Date Received | 02/06/1991 |
Decision Date | 05/09/1991 |
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
|
|
|