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FDA 510(k), K190610, Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
FDA 510(k), K190610, Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
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510(K) Number: K190610
Device Name: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Manufacturer: Sterilmed, Inc.
Device Classification Name: Single-Use Reprocessed Ultrasonic Surgical Instruments
Regulation Number:
Classification Product Code: NLQ
Date Received: 03/11/2019
Decision Date: 08/15/2019
Regulation Medical Specialty:
Device Name: Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Manufacturer: Sterilmed, Inc.
Device Classification Name: Single-Use Reprocessed Ultrasonic Surgical Instruments
Regulation Number:
Classification Product Code: NLQ
Date Received: 03/11/2019
Decision Date: 08/15/2019
Regulation Medical Specialty:
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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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