510(k) K953517
K953517 is an FDA 510(k) premarket notification submitted by Paragon Trade Brands, Inc. for the device "UNSCENTED MENSTRUAL PAD". The FDA issued a decision of Substantially Equivalent on Oct 26, 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 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 1995
- Date Received
- Jul 27, 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
- 510(k) Exempt
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.