The following data is part of a premarket notification filed by Bath Concept Cosmetics (dongguan) Co., Ltd with the FDA for Silicone Personal Lubricant.
| Device ID | K191654 |
| 510k Number | K191654 |
| Device Name: | SILICONE Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Bath Concept Cosmetics (Dongguan) Co., Ltd No.2, Dushang Industrial Zone, DaFen, WanJiang District Dongguan, CN 523052 |
| Contact | Jack Yin |
| Correspondent | Wei Zhang RGLM Consulting LLC 3302 171 St Pl SE Bathell, WA 98012 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-20 |
| Decision Date | 2020-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006114107 | K191654 | 000 |
| 00850030994028 | K191654 | 000 |