510(k) K040335
K040335 is an FDA 510(k) premarket notification submitted by Mooncup, LLC for the device "MOONCUP, STYLE A & B". The FDA issued a decision of Substantially Equivalent on March 30, 2005. The device falls under product code HHE (Cup, Menstrual), a Class II device regulated under 21 CFR 884.5400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2005
- Date Received
- February 11, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Menstrual
- Device Class
- Class II
- Regulation Number
- 884.5400
- Review Panel
- OB
- Submission Type
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.