510(k) K901664
K901664 is an FDA 510(k) premarket notification submitted by Personal Products Co. for the device "CAREFREE(TM) FESTIVA PANTYSHIELDS". The FDA issued a decision of Substantially Equivalent on June 22, 1990. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Personal Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1990
- Date Received
- April 10, 1990
- 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.