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FDA 510(k), K161378, joimax Electrosurgical Instruments
FDA 510(k), K161378, joimax Electrosurgical Instruments
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510(K) Number: K161378
Device Name: joimax Electrosurgical Instruments
Manufacturer: JOIMAX GMBH
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 05/18/2016
Decision Date: 11/02/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: joimax Electrosurgical Instruments
Manufacturer: JOIMAX GMBH
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 05/18/2016
Decision Date: 11/02/2016
Regulation Medical Specialty: General & Plastic Surgery
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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