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FDA 510(k), K202554, Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
FDA 510(k), K202554, Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
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510(K) Number: K202554
Device Name: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
Manufacturer: Stryker Sustainability Solutions
Device Classification Name: Single-Use Reprocessed Ultrasonic Surgical Instruments
Regulation Number:
Classification Product Code: NLQ
Date Received: 09/03/2020
Decision Date: 03/16/2021
Regulation Medical Specialty:
Device Name: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
Manufacturer: Stryker Sustainability Solutions
Device Classification Name: Single-Use Reprocessed Ultrasonic Surgical Instruments
Regulation Number:
Classification Product Code: NLQ
Date Received: 09/03/2020
Decision Date: 03/16/2021
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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