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FDA 510(k), K111831, MX-7000 MICROXEL
FDA 510(k), K111831, MX-7000 MICROXEL
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$149.00 USD
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510(K) Number: K111831
Device Name: MX-7000 MICROXEL
Manufacturer: BIO-MED U.S.A., INC.
Device Classification Name: powered laser surgical instrument with microbeam\fractional output
Regulation Number: 878.4810
Classification Product Code: ONG
Date Received: 06/28/2011
Decision Date: 12/19/2011
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MX-7000 MICROXEL
Manufacturer: BIO-MED U.S.A., INC.
Device Classification Name: powered laser surgical instrument with microbeam\fractional output
Regulation Number: 878.4810
Classification Product Code: ONG
Date Received: 06/28/2011
Decision Date: 12/19/2011
Regulation Medical Specialty: General & Plastic Surgery
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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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