Device Classification Name |
Condom
|
510(k) Number |
K874383 |
Device Name |
MENTOR PLUS (CONDOM) |
Applicant |
ARCON CORP. |
1421 2ND. AVENUE NW. |
STEWARTVILLE,
MN
55976
|
|
Applicant Contact |
RICHARD FRYAR |
Correspondent |
ARCON CORP. |
1421 2ND. AVENUE NW. |
STEWARTVILLE,
MN
55976
|
|
Correspondent Contact |
RICHARD FRYAR |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 10/26/1987 |
Decision Date | 03/07/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|