CivaDerm

Source, Brachytherapy, Radionuclide

CivaTech Oncology Inc.

The following data is part of a premarket notification filed by Civatech Oncology Inc. with the FDA for Civaderm.

Pre-market Notification Details

• Device ID: K191324
• 510k Number: K191324
• Device Name: CivaDerm
• Classification: Source, Brachytherapy, Radionuclide
• Applicant: CivaTech Oncology Inc. 2810 Meridian Parkway, Suite 152 Durham, NC 27713
• Contact: Suzanne Babcock
• Correspondent: Blix Winston; TAMM Net, Inc. 2600 Mullinix Mill Road Mt. Airy, MD 21771
• Product Code: KXK
• CFR Regulation Number: 892.5730 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-16
• Decision Date: 2019-09-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00869497000128	K191324	000