510(k) K842837
K842837 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "SAFE & SOFT MAXI SHILEDS". The FDA issued a decision of Substantially Equivalent on October 15, 1984. The device falls under product code HHD (Pad, Menstrual, Unscented), a Class I device regulated under 21 CFR 884.5435. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1984
- Date Received
- July 20, 1984
- 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.