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 |