The following data is part of a premarket notification filed by Dongkuk Techco Rubber Industries Sdn. Bhd. with the FDA for Multiple-brand Male Latex Condom (lubricated With Nonoxynol-9).
| Device ID | K990669 |
| 510k Number | K990669 |
| Device Name: | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) |
| Classification | Condom With Nonoxynol-9 |
| Applicant | DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. 7TH FL. MAYBAN TRUST BLDG. 3 PENANG ST. Penang, MY 10200 |
| Contact | Peter Park |
| Correspondent | Peter Park DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. 7TH FL. MAYBAN TRUST BLDG. 3 PENANG ST. Penang, MY 10200 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-05-17 |