510(k) K870299
K870299 is an FDA 510(k) premarket notification submitted by Redman, Inc. for the device "REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code KNN (Components, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Redman, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1987
- Date Received
- January 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Components, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3920
- Review Panel
- PM
- Submission Type