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FDA 510(k), K101889, DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
FDA 510(k), K101889, DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
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510(K) Number: K101889
Device Name: DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Manufacturer: PIVOTAL HEALTH SOLUTIONS
Device Classification Name: Equipment, Traction, Powered
Regulation Number: 890.5900
Classification Product Code: ITH
Date Received: 07/07/2010
Decision Date: 08/27/2010
Regulation Medical Specialty: Physical Medicine
Device Name: DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Manufacturer: PIVOTAL HEALTH SOLUTIONS
Device Classification Name: Equipment, Traction, Powered
Regulation Number: 890.5900
Classification Product Code: ITH
Date Received: 07/07/2010
Decision Date: 08/27/2010
Regulation Medical Specialty: Physical Medicine
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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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