Device Classification Name |
Dilator, Cervical, Hygroscopic-Laminaria
|
510(k) Number |
K881312 |
Device Name |
LAMINARIA |
Applicant |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
PARTHA BASUMALLIK |
Correspondent |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
PARTHA BASUMALLIK |
Regulation Number | 884.4260
|
Classification Product Code |
|
Date Received | 03/28/1988 |
Decision Date | 05/23/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|