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FDA 510(k), K070876, STRYKER TWIST DRILLS
FDA 510(k), K070876, STRYKER TWIST DRILLS
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510(K) Number: K070876
Device Name: STRYKER TWIST DRILLS
Manufacturer: TENNILLE FOLK
Device Classification Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation Number: HBE
Classification Product Code: 03/29/2007
Date Received: 04/27/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: STRYKER TWIST DRILLS
Manufacturer: TENNILLE FOLK
Device Classification Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation Number: HBE
Classification Product Code: 03/29/2007
Date Received: 04/27/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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