510(k) K010986
K010986 is an FDA 510(k) premarket notification submitted by Lunapads International Products, Ltd. for the device "LUNAPADS". The FDA issued a decision of Substantially Equivalent on Jun 13, 2001. The device falls under product code NUQ (Pad, Menstrual, Reusable), a Class I device regulated under 21 CFR 884.5435.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 13, 2001
- Date Received
- Apr 2, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pad, Menstrual, Reusable
- Device Class
- Class I
- Regulation Number
- 884.5435
- Review Panel
- OB
- Submission Type
- 510(k) Exempt
A reusable, unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic or synthetic material with an established safety profile.