HFD100 ROCKER ARM ACCESSORY

Holder, Head, Neurosurgical (skull Clamp)

IMRIS, INC.

The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Hfd100 Rocker Arm Accessory.

Pre-market Notification Details

Device IDK141950
510k NumberK141950
Device Name:HFD100 ROCKER ARM ACCESSORY
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant IMRIS, INC. 5101 Shady Oak Rd Minnetonka,  MN  55343
ContactKarissa Holcomb
CorrespondentKarissa Holcomb
IMRIS, INC. 5101 Shady Oak Rd Minnetonka,  MN  55343
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-18
Decision Date2014-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00857534006264 K141950 000

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