510(k) K210294
K210294 is an FDA 510(k) premarket notification submitted by Thai Nippon Rubber Industry Public Company Limited. for the device "One Touch Spiral Condom". The FDA issued a decision of Substantially Equivalent on September 23, 2021. 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
- September 23, 2021
- Date Received
- February 2, 2021
- 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