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FDA 510(k), K142418, I.T.S. Hand Locking Plates System - HLS
FDA 510(k), K142418, I.T.S. Hand Locking Plates System - HLS
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510(K) Number: K142418
Device Name: I.T.S. Hand Locking Plates System - HLS
Manufacturer: I.T.S. GmbH
Device Classification Name: plate, fixation, bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 08/28/2014
Decision Date: 09/26/2014
Regulation Medical Specialty: Orthopedic
Device Name: I.T.S. Hand Locking Plates System - HLS
Manufacturer: I.T.S. GmbH
Device Classification Name: plate, fixation, bone
Regulation Number: 888.3030
Classification Product Code: HRS
Date Received: 08/28/2014
Decision Date: 09/26/2014
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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