510(k) K201067
K201067 is an FDA 510(k) premarket notification submitted by Cupid Limited for the device "CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))". The FDA issued a decision of Substantially Equivalent on Aug 7, 2020. 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 7, 2020
- Date Received
- Apr 22, 2020
- 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)