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FDA 510(k), K182296, HyperFil-LV
FDA 510(k), K182296, HyperFil-LV
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$89.00 USD
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510(K) Number: K182296
Device Name: HyperFil-LV
Manufacturer: Parkell, Inc.
Device Classification Name: material, tooth shade, resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 08/24/2018
Decision Date: 12/14/2018
Regulation Medical Specialty: Dental
Device Name: HyperFil-LV
Manufacturer: Parkell, Inc.
Device Classification Name: material, tooth shade, resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 08/24/2018
Decision Date: 12/14/2018
Regulation Medical Specialty: Dental
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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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