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FDA 510(k), K013066, HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
FDA 510(k), K013066, HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
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$149.00 USD
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510(K) Number: K013066
Device Name: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Manufacturer: LAURA STORMS-TYLER
Device Classification Name: Ligator, Esophageal
Regulation Number: MND
Classification Product Code: 09/12/2001
Date Received: 12/11/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
Manufacturer: LAURA STORMS-TYLER
Device Classification Name: Ligator, Esophageal
Regulation Number: MND
Classification Product Code: 09/12/2001
Date Received: 12/11/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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