Device Classification Name |
Condom
|
510(k) Number |
K011378 |
Device Name |
JOE LUB HELMET CONDOM |
Applicant |
MARKETING SALES CONCEPTS, INC. (MSCI) |
200 RENAISSANCE COMPANY |
SUITE 111 |
ATLANTA,
GA
30308
|
|
Applicant Contact |
ERIC J ARTHUR |
Correspondent |
MARKETING SALES CONCEPTS, INC. (MSCI) |
200 RENAISSANCE COMPANY |
SUITE 111 |
ATLANTA,
GA
30308
|
|
Correspondent Contact |
ERIC J ARTHUR |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/03/2001 |
Decision Date | 03/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|