510(k) K171213
K171213 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Public Company Limited. for the device "One Touch Condom with Benzocaine". The FDA issued a decision of Substantially Equivalent on January 12, 2018. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Thai Nippon Rubber Industry Public Company Limited. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2018
- Date Received
- April 25, 2017
- 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