IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

Holder, Head, Neurosurgical (skull Clamp)

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imris Mr/x-ray Head Fixation Device (hfd).

Pre-market Notification Details

Device IDK113748
510k NumberK113748
Device Name:IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb,  CA R3t 1n5
ContactSanjay Shah
CorrespondentSanjay Shah
IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb,  CA R3t 1n5
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-21
Decision Date2012-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857534006028 K113748 000
00857534006004 K113748 000
00857534006455 K113748 000

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