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 |