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FDA 510(k), K182036, NeuroBlate System
FDA 510(k), K182036, NeuroBlate System
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510(K) Number: K182036
Device Name: NeuroBlate System
Manufacturer: Monteris Medical
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 07/30/2018
Decision Date: 10/15/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NeuroBlate System
Manufacturer: Monteris Medical
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 07/30/2018
Decision Date: 10/15/2018
Regulation Medical Specialty: General & Plastic Surgery
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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. Learn more about Fast-Track Requests here.
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