Device Classification Name |
condom
|
510(k) Number |
K150828 |
Device Name |
O-RING Condom |
Applicant |
O-RING Products LLC |
4012 Grand Manor Court, #208 |
Raleigh,
NC
27612
|
|
Applicant Contact |
William Mistler |
Correspondent |
O-RING Products LLC |
4012 Grand Manor Court, #208 |
Raliegh,
NC
27612
|
|
Correspondent Contact |
William Mistler |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/30/2015 |
Decision Date | 12/18/2015 |
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
|
|
|