The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Male Natural Rubber Latex Condom.
Device ID | K053367 |
510k Number | K053367 |
Device Name: | MALE NATURAL RUBBER LATEX CONDOM |
Classification | Condom |
Applicant | INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan, MY 42000 |
Contact | Goh Miah Kiat |
Correspondent | Goh Miah Kiat INNOLATEX SDN. BHD PANDAMARAN INDUSTRIAL ESTATE PORT KLANG Selangor Darul Ehsan, MY 42000 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-05 |
Decision Date | 2006-02-21 |