510(k) K953666
K953666 is an FDA 510(k) premarket notification submitted by Paragon Trade Brands, Inc. for the device "UNSCENTED MENSTRAL PAD WITH WINGS". The FDA issued a decision of Substantially Equivalent on September 27, 1995. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Paragon Trade Brands, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1995
- Date Received
- August 7, 1995
- 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.