The following data is part of a premarket notification filed by Church & Dwight Co., Inc with the FDA for Trojantm Azul Personal Lubricant (h2o Sensitive Touch Personal Lubricant).
| Device ID | K180764 |
| 510k Number | K180764 |
| Device Name: | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) |
| Classification | Lubricant, Personal |
| 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 | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600999379 | K180764 | 000 |
| 00022600000204 | K180764 | 000 |