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FDA 510(k), K030315, MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
FDA 510(k), K030315, MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
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510(K) Number: K030315
Device Name: MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
Manufacturer: RONALD R NEWTON
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: KNS
Classification Product Code: 01/30/2003
Date Received: 02/27/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
Manufacturer: RONALD R NEWTON
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: KNS
Classification Product Code: 01/30/2003
Date Received: 02/27/2003
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
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