510(k) K830259
K830259 is an FDA 510(k) premarket notification submitted by Ritmed, Inc. for the device "PROTET SOAP & WASH MITT". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code GED (Brush, Dermabrasion, Manual), a Class I device regulated under 21 CFR 878.4800. Ritmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Dermabrasion, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type