Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K092870 |
Device Name |
NON-STERILE DISPOSABLE VAGINAL SPECULUM |
Applicant |
KUNSHAN DEYI PLASTIC CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
KUNSHAN DEYI PLASTIC CO., LTD. |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/18/2009 |
Decision Date | 02/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|