510(k) K161195
K161195 is an FDA 510(k) premarket notification submitted by M3 Global Enterprises, LLC for the device "Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)". The FDA issued a decision of Substantially Equivalent on Aug 25, 2016. 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
- Aug 25, 2016
- Date Received
- Apr 27, 2016
- 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)