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FDA 510(k), K140273, EQUALIZER OCCLUSION BALLOON CATHETER
FDA 510(k), K140273, EQUALIZER OCCLUSION BALLOON CATHETER
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510(K) Number: K140273
Device Name: EQUALIZER OCCLUSION BALLOON CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 02/03/2014
Decision Date: 07/22/2014
Regulation Medical Specialty: Cardiovascular
Device Name: EQUALIZER OCCLUSION BALLOON CATHETER
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 02/03/2014
Decision Date: 07/22/2014
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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