510(k) K821256
K821256 is an FDA 510(k) premarket notification submitted by The Langer Group for the device "COUNTER-ROTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 1982. The device falls under product code ITN (Splint, Denis Brown), a Class I device regulated under 21 CFR 890.3675. The Langer Group has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1982
- Date Received
- April 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Denis Brown
- Device Class
- Class I
- Regulation Number
- 890.3675
- Review Panel
- PM
- Submission Type