The following data is part of a premarket notification filed by Church & Dwight Co., Inc with the FDA for Trojan Chain Reaction Natural Rubber Latex Condom With Sensate Lubricant.
| Device ID | K180104 |
| 510k Number | K180104 |
| Device Name: | Trojan Chain Reaction Natural Rubber Latex Condom With Sensate Lubricant |
| Classification | Condom |
| Applicant | Church & Dwight Co., Inc 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Contact | Joelle Reinson |
| Correspondent | Joelle Reinson Church & Dwight Co., Inc 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-03-14 |
| Summary: | summary |