510(k) K821682
K821682 is an FDA 510(k) premarket notification submitted by Surgical Appliance Industries, Inc. for the device "TRUNCAL ORTHOSIS". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code IQE (Orthosis, Lumbar), a Class I device regulated under 21 CFR 890.3490. Surgical Appliance Industries, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1982
- Date Received
- June 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Lumbar
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type