The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Nirvana B Personal Lubricant.
| Device ID | K120751 |
| 510k Number | K120751 |
| Device Name: | NIRVANA B PERSONAL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Contact | Emily Perez |
| Correspondent | Emily Perez CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-12 |
| Decision Date | 2012-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600092650 | K120751 | 000 |