The following data is part of a premarket notification filed by Suretex Limited with the FDA for Ofnat Lubricant (l15).
| Device ID | K221243 |
| 510k Number | K221243 |
| Device Name: | OFNat Lubricant (L15) |
| Classification | Lubricant, Personal |
| Applicant | Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin, TH 84130 |
| Contact | KC Nguyen |
| Correspondent | Carole C Carey C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80070907101120 | K221243 | 000 |
| 10070907001155 | K221243 | 000 |
| 00070907001141 | K221243 | 000 |
| 18859798100374 | K221243 | 000 |
| 08859798100360 | K221243 | 000 |
| 08859798100353 | K221243 | 000 |
| 08859798100339 | K221243 | 000 |