510(k) K854467
K854467 is an FDA 510(k) premarket notification submitted by Nortex USA, Inc. for the device "S.T.P.B SOFT TISSUES PROTECTIVES BLADES". The FDA issued a decision of Substantially Equivalent on March 12, 1986. The device falls under product code EEJ (Guard, Disk), a Class I device regulated under 21 CFR 872.6010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1986
- Date Received
- November 6, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guard, Disk
- Device Class
- Class I
- Regulation Number
- 872.6010
- Review Panel
- DE
- Submission Type