FDA 510(k), K052051, OMNI SPHINCTEROTOME

FDA 510(k), K052051, OMNI SPHINCTEROTOME

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510(K) Number: K052051
Device Name: OMNI SPHINCTEROTOME
Manufacturer:
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 07/29/2005
Decision Date: 08/05/2005
Regulation Medical Specialty: Gastroenterology/Urology
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