Device Classification Name |
Condom
|
510(k) Number |
K871020 |
Device Name |
KANGLE CONDOM |
Applicant |
LINDLEY COMPANY, INC. |
224 EAST OLIVE AVE. |
SUITE 305 |
BURBANK,
CA
91502
|
|
Applicant Contact |
LILY SHEN |
Correspondent |
LINDLEY COMPANY, INC. |
224 EAST OLIVE AVE. |
SUITE 305 |
BURBANK,
CA
91502
|
|
Correspondent Contact |
LILY SHEN |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/16/1987 |
Decision Date | 07/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|