The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Co., Ltd. with the FDA for Flavored Male Latex Condom.
| Device ID | K011253 |
| 510k Number | K011253 |
| Device Name: | FLAVORED MALE LATEX CONDOM |
| Classification | Condom |
| 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 | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-24 |
| Decision Date | 2001-07-20 |