The following data is part of a premarket notification filed by Ls Rubber Sdn Bhd with the FDA for Maxima, Trustex, Ria And Premium El Les Condoms.
| Device ID | K981955 |
| 510k Number | K981955 |
| Device Name: | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS |
| Classification | Condom With Nonoxynol-9 |
| Applicant | LS RUBBER SDN BHD 11535 PARK WOODS CIRCLE SUITE B Alpharetta, GA 30005 |
| Contact | Rajil Vohra |
| Correspondent | Rajil Vohra LS RUBBER SDN BHD 11535 PARK WOODS CIRCLE SUITE B Alpharetta, GA 30005 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1999-03-15 |