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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spine, plate, laminoplasty, metal
510(k) Number K121276
Device Name NEURO VENTION LAMINPLASTY PLATING SYSTEM
Applicant
NEUROVENTION LLC
4628 NORTHPARK DRIVE
MEREDITH MAY,  CO  80918
Applicant Contact MEREDITH MAY
Correspondent
NEUROVENTION LLC
4628 NORTHPARK DRIVE
MEREDITH MAY,  CO  80918
Correspondent Contact MEREDITH MAY
Regulation Number888.3050
Classification Product Code
NQW  
Date Received04/27/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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