The following data is part of a premarket notification filed by Ls Rubber Sdn Bhd with the FDA for Maxima, Trustex, Ria And Premium Condoms.
| Device ID | K980964 |
| 510k Number | K980964 |
| Device Name: | MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS |
| Classification | Condom |
| Applicant | LS RUBBER SDN BHD 2443 FILLMORE ST. SUITE 135 San Francisco, CA 91115 |
| Contact | Mohamad Firdaos Bin Mohamed |
| Correspondent | Mohamad Firdaos Bin Mohamed LS RUBBER SDN BHD 2443 FILLMORE ST. SUITE 135 San Francisco, CA 91115 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1999-03-12 |