Device Classification Name |
speculum, vaginal, nonmetal, fiberoptic
|
510(k) Number |
K902516 |
Device Name |
NEW LENGTH SUGITA APPLIERS |
Applicant |
SIMS SURGICAL, INC. |
15 KIT ST. |
P.O. BOX 724 |
KEENE,
NH
03431
|
|
Applicant Contact |
JOHN D FORSTER |
Correspondent |
SIMS SURGICAL, INC. |
15 KIT ST. |
P.O. BOX 724 |
KEENE,
NH
03431
|
|
Correspondent Contact |
JOHN D FORSTER |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 06/07/1990 |
Decision Date | 07/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|