The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for 'one Touch' Latex Condom With Nonoxynol-9.
| Device ID | K001978 |
| 510k Number | K001978 |
| Device Name: | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 |
| Classification | Condom With Nonoxynol-9 |
| Applicant | THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Contact | Eli J Carter |
| Correspondent | Eli J Carter THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-29 |
| Decision Date | 2000-08-08 |