510(k) K181844
K181844 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Public Company, Ltd. for the device "One Touch". The FDA issued a decision of Substantially Equivalent on Apr 15, 2019. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 15, 2019
- Date Received
- Jul 11, 2018
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)