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FDA 510(k), K083822, LASER TOUCHONE
FDA 510(k), K083822, LASER TOUCHONE
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510(K) Number: K083822
Device Name: LASER TOUCHONE
Manufacturer: LASER HEALTH TECHNOLOGIES, LLC
Device Classification Name: stimulator, nerve, transcutaneous, for pain relief
Regulation Number: 882.5890
Classification Product Code: GZJ
Date Received: 12/22/2008
Decision Date: 05/06/2009
Regulation Medical Specialty: Neurology
Device Name: LASER TOUCHONE
Manufacturer: LASER HEALTH TECHNOLOGIES, LLC
Device Classification Name: stimulator, nerve, transcutaneous, for pain relief
Regulation Number: 882.5890
Classification Product Code: GZJ
Date Received: 12/22/2008
Decision Date: 05/06/2009
Regulation Medical Specialty: Neurology
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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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