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 |