The following data is part of a premarket notification filed by Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa with the FDA for Joy Drops (tm) Natural Personal Lubricant Gel.
| Device ID | K140506 |
| 510k Number | K140506 |
| Device Name: | JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL |
| Classification | Lubricant, Personal |
| Applicant | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 2237 CHESTNUT STREET San Francisco, CA 94123 |
| Contact | Michael Scott |
| Correspondent | Michael Scott TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA 2237 CHESTNUT STREET San Francisco, CA 94123 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2015-04-17 |
| Summary: | summary |