Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K963377 |
Device Name |
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC |
Applicant |
NORTH EOS INDUSTRIES, INC. |
54, LANE 1, BEEN ST. |
TUNG-SHIH |
TAICHUNG HSIEN,
TW
|
|
Applicant Contact |
SARA CHEN |
Correspondent |
NORTH EOS INDUSTRIES, INC. |
54, LANE 1, BEEN ST. |
TUNG-SHIH |
TAICHUNG HSIEN,
TW
|
|
Correspondent Contact |
SARA CHEN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 08/27/1996 |
Decision Date | 10/04/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|