The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Public Company Limited with the FDA for One Touch Condom With Benzocaine.
| Device ID | K171213 |
| 510k Number | K171213 |
| Device Name: | One Touch Condom With Benzocaine |
| Classification | Condom |
| Applicant | Thai Nippon Rubber Industry Public Company Limited 1 Charoenrat Road, Thungwatdon, Sathon Bangkok, TH 10120 |
| Contact | Pisut Chanwatarungkull (pete) |
| Correspondent | Kevin Walls Thai Nippon Rubber Industry Public Company Limited 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-04-25 |
| Decision Date | 2018-01-12 |