510(k) K911637
K911637 is an FDA 510(k) premarket notification submitted by Personal Products Co. for the device "STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code HAD (Rongeur, Powered), a Class II device regulated under 21 CFR 882.4845. Personal Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 1991
- Date Received
- April 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Powered
- Device Class
- Class II
- Regulation Number
- 882.4845
- Review Panel
- NE
- Submission Type