The following data is part of a premarket notification filed by Johnson & Johnson Healthcare Products with the FDA for K-y Brand Liquibeads.
| Device ID | K122061 |
| 510k Number | K122061 |
| Device Name: | K-Y BRAND LIQUIBEADS |
| Classification | Lubricant, Personal |
| Applicant | JOHNSON & JOHNSON HEALTHCARE PRODUCTS 185 TABOR ROAD Morris Plains, NJ 07950 |
| Contact | Lorna-jane Bremer |
| Correspondent | Lorna-jane Bremer JOHNSON & JOHNSON HEALTHCARE PRODUCTS 185 TABOR ROAD Morris Plains, NJ 07950 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-13 |
| Decision Date | 2013-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20067981160462 | K122061 | 000 |