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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 K050025
Device Name NANOSS BONE VOID FILLER
Applicant
ANGSTROM MEDICA, INC.
4329 GRAYDON ROAD
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
ANGSTROM MEDICA, INC.
4329 GRAYDON ROAD
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3045
Classification Product Code
MQV  
Date Received01/06/2005
Decision Date 02/03/2005
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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