The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Spermicidal Lubricated Male Latex Condom.
Device ID | K010178 |
510k Number | K010178 |
Device Name: | SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
Classification | Condom With Nonoxynol-9 |
Applicant | INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
Contact | Chang Au-kau |
Correspondent | Chang Au-kau INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
Product Code | LTZ |
CFR Regulation Number | 884.5310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-01-19 |
Decision Date | 2001-04-27 |