510(k) K934468
K934468 is an FDA 510(k) premarket notification submitted by Gatewood Splints for the device "SLIP-ON FIXATION SPLINT (SFS)". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code EHO (Bar, Preformed), a Class I device regulated under 21 CFR 872.3165.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1994
- Date Received
- September 10, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bar, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3165
- Review Panel
- DE
- Submission Type