510(k) K022626
K022626 is an FDA 510(k) premarket notification submitted by Raymond Industrial, Ltd. for the device "MOISTURESTAY (REVLON)". The FDA issued a decision of Substantially Equivalent on October 29, 2002. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Raymond Industrial, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2002
- Date Received
- August 7, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Paraffin
- Device Class
- Class II
- Regulation Number
- 890.5110
- Review Panel
- PM
- Submission Type