Device Classification Name |
condom
|
510(k) Number |
K192669 |
Device Name |
Extremely Thin 003, ZERO ZERO THREE |
Applicant |
Okamoto U.S.A., Inc. |
18 King Street |
Stratford,
CT
06615
|
|
Applicant Contact |
Yu Tadano |
Correspondent |
Hyman, Phelps & McNamara, P.C. |
Washington,
DC
20005
|
|
Correspondent Contact |
Jeffrey N. Gibbs |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 09/25/2019 |
Decision Date | 07/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|