510(k) K770891
K770891 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "SPLINH, FOREARM". The FDA issued a decision of Substantially Equivalent on May 26, 1977. The device falls under product code IQM (Splint, Temporary Training), a Class I device regulated under 21 CFR 890.3025. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1977
- Date Received
- May 16, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Temporary Training
- Device Class
- Class I
- Regulation Number
- 890.3025
- Review Panel
- PM
- Submission Type