Device Classification Name |
Amniotome
|
510(k) Number |
K951148 |
Device Name |
OBSTI-HOOK |
Applicant |
ONLI |
506 WICKHAM WAY |
GAHANNA,
OH
43230
|
|
Applicant Contact |
CHARLES T SAMPSON, III |
Correspondent |
ONLI |
506 WICKHAM WAY |
GAHANNA,
OH
43230
|
|
Correspondent Contact |
CHARLES T SAMPSON, III |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 03/13/1995 |
Decision Date | 06/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|