Device Classification Name |
Remover, Intrauterine Device, Contraceptive, Hook-Type
|
510(k) Number |
K842295 |
Device Name |
INTRAUTERINE DEVICE REMOVER |
Applicant |
PREMIER DENTAL PRODUCTS CO. |
P.O. BOX 111 |
NORRISTOWN,
PA
19404
|
|
Applicant Contact |
WILLIAM J FREZEL |
Correspondent |
PREMIER DENTAL PRODUCTS CO. |
P.O. BOX 111 |
NORRISTOWN,
PA
19404
|
|
Correspondent Contact |
WILLIAM J FREZEL |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 06/11/1984 |
Decision Date | 10/12/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|