Device Classification Name |
Condom
|
510(k) Number |
K081413 |
Device Name |
TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM |
Applicant |
DAILIAN LATEX COMPANY, LTD. |
NO. 188 MALAN NORTH STREET |
SHAHEKOU DISTRICT |
DAILIAN CITY, LIAONING,
CN
116021
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/20/2008 |
Decision Date | 10/24/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|