510(k) K162919
K162919 is an FDA 510(k) premarket notification submitted by Zhejiang Xiangban Latex Products Co., Ltd. for the device "Male Latex Condoms". The FDA issued a decision of Substantially Equivalent on Mar 7, 2017. 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
- Mar 7, 2017
- Date Received
- Oct 18, 2016
- Clearance Type
- Traditional
- 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)