510(k) K780489
K780489 is an FDA 510(k) premarket notification submitted by Marullo, Baldwin, Frieden, Gatewood, for the device "SPINE BOARD". The FDA issued a decision of Substantially Equivalent on April 12, 1978. The device falls under product code IQF (Orthosis, Cervical-Thoracic, Rigid), a Class I device regulated under 21 CFR 890.3490.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1978
- Date Received
- March 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cervical-Thoracic, Rigid
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type