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FDA 510(k), K192891, Laparoscope Lens Shield Device (LENS)
FDA 510(k), K192891, Laparoscope Lens Shield Device (LENS)
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$149.00 USD
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510(K) Number: K192891
Device Name: Laparoscope Lens Shield Device (LENS)
Manufacturer: Tsung-Yu Hsieh
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: 10/10/2019
Date Received: 11/07/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Laparoscope Lens Shield Device (LENS)
Manufacturer: Tsung-Yu Hsieh
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: 10/10/2019
Date Received: 11/07/2019
Decision Date: Substantially Equivalent (SESE)
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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