510(k) K850956
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1985
- Date Received
- March 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Menstrual, Scented, Scented-Deodorized
- Device Class
- Class II
- Regulation Number
- 884.5425
- Review Panel
- OB
- Submission Type
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).