The following data is part of a premarket notification filed by Suretex Limited with the FDA for Microthin Natural Rubber Latex Condom.
Device ID | K213921 |
510k Number | K213921 |
Device Name: | Microthin Natural Rubber Latex Condom |
Classification | Condom |
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 | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-15 |
Decision Date | 2022-04-28 |