Device Classification Name |
Dilator, Cervical, Hygroscopic-Laminaria
|
510(k) Number |
K955072 |
Device Name |
LAMINARIA |
Applicant |
CTI CORP., LTD. |
607 ELMIRA RD. |
VACAVILLE,
CA
95687
|
|
Applicant Contact |
OSCAR PELAEZ TAN |
Correspondent |
CTI CORP., LTD. |
607 ELMIRA RD. |
VACAVILLE,
CA
95687
|
|
Correspondent Contact |
OSCAR PELAEZ TAN |
Regulation Number | 884.4260 |
Classification Product Code |
|
Date Received | 11/06/1995 |
Decision Date | 05/22/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|