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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filler, bone void, calcium compound
510(k) Number K111944
Device Name NB3D BONE VOID FILLER
Applicant
PIONEER SURGICAL TECHNOLOGY, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/08/2011
Decision Date 11/22/2011
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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