The following data is part of a premarket notification filed by Ls Rubber Sdn Bhd with the FDA for Natural And Colored Latex Condom With Flavors.
Device ID | K020633 |
510k Number | K020633 |
Device Name: | NATURAL AND COLORED LATEX CONDOM WITH FLAVORS |
Classification | Condom |
Applicant | LS RUBBER SDN BHD 11535 PARK WOODS CIRCLE SUITE B Alpharetta, GA 30005 |
Contact | Rajila Vohra |
Correspondent | Rajila Vohra LS RUBBER SDN BHD 11535 PARK WOODS CIRCLE SUITE B Alpharetta, GA 30005 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-27 |
Decision Date | 2002-05-15 |
Summary: | summary |