The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Azul Personal Lubricant.
| Device ID | K141034 |
| 510k Number | K141034 |
| Device Name: | AZUL PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BLVD Ewing, NJ 08628 |
| Contact | Joseph Cicone |
| Correspondent | Joseph Cicone 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 | 2014-04-22 |
| Decision Date | 2014-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600000068 | K141034 | 000 |
| 00022600000051 | K141034 | 000 |
| 00022600999379 | K141034 | 000 |