510(k) K884976
K884976 is an FDA 510(k) premarket notification submitted by Mcdowell Ent., Inc. for the device "MICRO-STRAIGHT POSTURE TRAINING DEVICE". The FDA issued a decision of Substantially Equivalent on June 9, 1989. The device falls under product code LZW (Monitor, Spine Curvature), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1989
- Date Received
- November 30, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Spine Curvature
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type