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FDA 510(k), K161554, ENDOFLATOR 40, ENDOFLATOR 50
FDA 510(k), K161554, ENDOFLATOR 40, ENDOFLATOR 50
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$149.00 USD
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510(K) Number: K161554
Device Name: ENDOFLATOR 40, ENDOFLATOR 50
Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 06/06/2016
Decision Date: 03/02/2017
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: ENDOFLATOR 40, ENDOFLATOR 50
Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 06/06/2016
Decision Date: 03/02/2017
Regulation Medical Specialty: Obstetrics/Gynecology
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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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