510(k) K833726
K833726 is an FDA 510(k) premarket notification submitted by Bionic Instrument Corp. for the device "KLEIN WIRE TIGHTENER/BIONIC WIRE". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code HXS (Twister, Wire), a Class I device regulated under 21 CFR 888.4540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1983
- Date Received
- October 24, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Twister, Wire
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type