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FDA 510(k), K193601, Single Use Electrosurgical Knife
FDA 510(k), K193601, Single Use Electrosurgical Knife
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510(K) Number: K193601
Device Name: Single Use Electrosurgical Knife
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 12/23/2019
Decision Date: 07/24/2020
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Single Use Electrosurgical Knife
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 12/23/2019
Decision Date: 07/24/2020
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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