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FDA 510(k), K120630, AZUR DETACHABLE 18
FDA 510(k), K120630, AZUR DETACHABLE 18
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510(K) Number: K120630
Device Name: AZUR DETACHABLE 18
Manufacturer: MICRO VENTION, INC.
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 03/01/2012
Decision Date: 03/28/2012
Regulation Medical Specialty: Cardiovascular
Device Name: AZUR DETACHABLE 18
Manufacturer: MICRO VENTION, INC.
Device Classification Name: Device, Vascular, For Promoting Embolization
Regulation Number: 870.3300
Classification Product Code: KRD
Date Received: 03/01/2012
Decision Date: 03/28/2012
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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