The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Male Latex Comdom With Dotted Surface.
Device ID | K001221 |
510k Number | K001221 |
Device Name: | MALE LATEX COMDOM WITH DOTTED SURFACE |
Classification | Condom |
Applicant | PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
Contact | Koi-yong Lim |
Correspondent | Koi-yong Lim PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-17 |
Decision Date | 2000-05-19 |