FDA 510(k), K192272, Wolf445nm
FDA 510(k), K192272, Wolf445nm
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510(K) Number: K192272
Device Name: Wolf445nm
Manufacturer: A.R.C. Laser GmbH
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 08/22/2019
Decision Date: 03/17/2020
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Wolf445nm
Manufacturer: A.R.C. Laser GmbH
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 08/22/2019
Decision Date: 03/17/2020
Regulation Medical Specialty: General & Plastic Surgery
- 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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