Device Classification Name |
Condom
|
510(k) Number |
K010371 |
Device Name |
LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT |
Applicant |
SURETEX, LTD. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Applicant Contact |
LON D MCILVAIN |
Correspondent |
SURETEX, LTD. |
1500 INDUSTRIAL RD. |
P.O. BOX 1252 |
DOTHAN,
AL
36302
|
|
Correspondent Contact |
LON D MCILVAIN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/07/2001 |
Decision Date | 04/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|