510(k) K782111
K782111 is an FDA 510(k) premarket notification submitted by Intl. Playtex, Inc. for the device "PADS, MINI, MAXI DEODORANT". The FDA issued a decision of Substantially Equivalent on Jan 8, 1979. The device falls under product code HHL (Pad, Menstrual, Scented, Scented-Deodorized), a Class II device regulated under 21 CFR 884.5425. Intl. Playtex, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 1979
- Date Received
- Dec 18, 1978
- 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
- 510(k) Exempt
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).