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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K141644
Device Name INNOVASIS CRANIAL SYSTEM
Applicant
INNOVASIS, INC.
614 E 3900 S
SALT LAKE CITY,  UT  84107
Applicant Contact MARSHALL MCCARTY
Correspondent
INNOVASIS, INC.
614 E 3900 S
SALT LAKE CITY,  UT  84107
Correspondent Contact MARSHALL MCCARTY
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received06/19/2014
Decision Date 11/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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