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FDA 510(k), K173310, SmartTouch
FDA 510(k), K173310, SmartTouch
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510(K) Number: K173310
Device Name: SmartTouch
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 10/18/2017
Decision Date: 03/26/2018
Regulation Medical Specialty: Anesthesiology
Device Name: SmartTouch
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 10/18/2017
Decision Date: 03/26/2018
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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