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FDA 510(k), K131278, MONTERIS MEDICAL NEUROBLATE SYSTEM
FDA 510(k), K131278, MONTERIS MEDICAL NEUROBLATE SYSTEM
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510(K) Number: K131278
Device Name: MONTERIS MEDICAL NEUROBLATE SYSTEM
Manufacturer: MONTERIS MEDICAL, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/06/2013
Decision Date: 07/11/2013
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MONTERIS MEDICAL NEUROBLATE SYSTEM
Manufacturer: MONTERIS MEDICAL, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 05/06/2013
Decision Date: 07/11/2013
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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