VARIOSURG

Drill, Bone, Powered

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Variosurg.

Pre-market Notification Details

• Device ID: K073678
• 510k Number: K073678
• Device Name: VARIOSURG
• Classification: Drill, Bone, Powered
• Applicant: NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005
• Contact: Keith Barritt
• Correspondent: Keith Barritt; NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005
• Product Code: DZI
• CFR Regulation Number: 872.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-12-28
• Decision Date: 2008-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04560264508385	K073678	000
04560264562813	K073678	000
04560264562820	K073678	000
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