Device Classification Name |
condom
|
510(k) Number |
K990925 |
Device Name |
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) |
Applicant |
HARDCOVER PRODUCTS, INC. |
55 ADMINISTRATION RD., UNIT 12 |
CONCORD, ONTARIO,
CA
L4K 4G9
|
|
Applicant Contact |
GERRY GLAZER |
Correspondent |
HARDCOVER PRODUCTS, INC. |
55 ADMINISTRATION RD., UNIT 12 |
CONCORD, ONTARIO,
CA
L4K 4G9
|
|
Correspondent Contact |
GERRY GLAZER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/19/1999 |
Decision Date | 06/17/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|