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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K141950
Device Name HFD100 ROCKER ARM ACCESSORY
Applicant
Imris, Inc.
5101 Shady Oak Rd.
Minnetonka,  MN  55343
Applicant Contact KARISSA HOLCOMB
Correspondent
Imris, Inc.
5101 Shady Oak Rd.
Minnetonka,  MN  55343
Correspondent Contact KARISSA HOLCOMB
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/18/2014
Decision Date 09/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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