Device Classification Name |
condom
|
510(k) Number |
K841600 |
Device Name |
CASABLANCA |
Applicant |
ARCON CORP. |
1421 2ND. AVENUE NW. |
STEWARTVILLE,
MN
55976
|
|
Applicant Contact |
ANTHONY J CONWAY |
Correspondent |
ARCON CORP. |
1421 2ND. AVENUE NW. |
STEWARTVILLE,
MN
55976
|
|
Correspondent Contact |
ANTHONY J CONWAY |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/18/1984 |
Decision Date | 11/29/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|