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 |