HEAD FIXATION ARC AND TABLE BASE

Holder, Head, Neurosurgical (skull Clamp)

SURGIVISION, INC.

The following data is part of a premarket notification filed by Surgivision, Inc. with the FDA for Head Fixation Arc And Table Base.

Pre-market Notification Details

• Device ID: K091439
• 510k Number: K091439
• Device Name: HEAD FIXATION ARC AND TABLE BASE
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071
• Contact: J. Harvey Knauss
• Correspondent: J. Harvey Knauss; SURGIVISION, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071
• Product Code: HBL
• CFR Regulation Number: 882.4460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-14
• Decision Date: 2009-08-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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