The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Xoxo Thin Male Natural Rubber Latex Condom With Silicone And Aloe Lubricant.
| Device ID | K161545 |
| 510k Number | K161545 |
| Device Name: | Trojan XOXO Thin Male Natural Rubber Latex Condom With Silicone And Aloe Lubricant |
| Classification | Condom |
| Applicant | CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD Ewing, NJ 08628 |
| Contact | Lisa Burns |
| Correspondent | Lisa Burns 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 | 2016-06-03 |
| Decision Date | 2016-08-26 |
| Summary: | summary |