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FDA 510(k), K180396, miraDry System
FDA 510(k), K180396, miraDry System
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$149.00 USD
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510(K) Number: K180396
Device Name: miraDry System
Manufacturer: Miramar Labs, Inc.
Device Classification Name: system, ablation, microwave and accessories
Regulation Number: 878.4400
Classification Product Code: NEY
Date Received: 02/13/2018
Decision Date: 03/15/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: miraDry System
Manufacturer: Miramar Labs, Inc.
Device Classification Name: system, ablation, microwave and accessories
Regulation Number: 878.4400
Classification Product Code: NEY
Date Received: 02/13/2018
Decision Date: 03/15/2018
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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