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FDA 510(k), K130996, ERCHONIA EMERGE
FDA 510(k), K130996, ERCHONIA EMERGE
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510(K) Number: K130996
Device Name: ERCHONIA EMERGE
Manufacturer: ERCHONIA MEDICAL, INC.
Device Classification Name: powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Number: 890.5500
Classification Product Code: NHN
Date Received: 04/10/2013
Decision Date: 09/16/2013
Regulation Medical Specialty: Physical Medicine
Device Name: ERCHONIA EMERGE
Manufacturer: ERCHONIA MEDICAL, INC.
Device Classification Name: powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Number: 890.5500
Classification Product Code: NHN
Date Received: 04/10/2013
Decision Date: 09/16/2013
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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