Device Classification Name |
Condom
|
510(k) Number |
K842185 |
Device Name |
PROTEX CONTRACEPT PLUS W/SPERM-LUB |
Applicant |
NATIONAL SANITARY LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NATIONAL SANITARY LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/01/1984 |
Decision Date | 07/31/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|