510(k) K162511
K162511 is an FDA 510(k) premarket notification submitted by Lelo, Inc. for the device "LELO RESPECT HEX Natural Rubber Latex Condom". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Lelo, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2017
- Date Received
- September 8, 2016
- Clearance Type
- Special
- 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