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FDA 510(k), K180627, Macroduct Advanced Model 3710
FDA 510(k), K180627, Macroduct Advanced Model 3710
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510(K) Number: K180627
Device Name: Macroduct Advanced Model 3710
Manufacturer: ELITechGroup Inc.
Device Classification Name: device, iontophoresis, specific uses
Regulation Number: 890.5525
Classification Product Code: KTB
Date Received: 03/09/2018
Decision Date: 07/27/2018
Regulation Medical Specialty: Physical Medicine
Device Name: Macroduct Advanced Model 3710
Manufacturer: ELITechGroup Inc.
Device Classification Name: device, iontophoresis, specific uses
Regulation Number: 890.5525
Classification Product Code: KTB
Date Received: 03/09/2018
Decision Date: 07/27/2018
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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