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FDA 510(k), K153229, Superbium
FDA 510(k), K153229, Superbium
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510(K) Number: K153229
Device Name: Superbium
Manufacturer: BIOS S.R.L
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 11/06/2015
Decision Date: 04/12/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Superbium
Manufacturer: BIOS S.R.L
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 11/06/2015
Decision Date: 04/12/2016
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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