510(k) K770223
K770223 is an FDA 510(k) premarket notification submitted by Robert R. Moore for the device "HEAVY FOAM HEEL & ELBOW PROTECTORS". The FDA issued a decision of Substantially Equivalent on February 23, 1977. The device falls under product code IPM (Cover, Limb), a Class I device regulated under 21 CFR 890.3025. Robert R. Moore has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1977
- Date Received
- February 3, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Limb
- Device Class
- Class I
- Regulation Number
- 890.3025
- Review Panel
- PM
- Submission Type