510(k) K870298
K870298 is an FDA 510(k) premarket notification submitted by Redman, Inc. for the device "REDMAN ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Redman, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1987
- Date Received
- January 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3910
- Review Panel
- PM
- Submission Type