510(k) K940468
K940468 is an FDA 510(k) premarket notification submitted by B.A. Wholesale, Inc. for the device "FEMININE MAXI PADS". The FDA issued a decision of Substantially Equivalent on May 26, 1994. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1994
- Date Received
- February 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Menstrual, Unscented
- Device Class
- Class I
- Regulation Number
- 884.5435
- Review Panel
- OB
- Submission Type
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.