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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K121936
Device Name NAVIOPFS
Applicant
Blue Belt Technologies, Inc.
2828 Liberty Ave.
Suite 100
Pittsburgh,  PA  15222
Applicant Contact RICHARD G CONFER
Correspondent
Blue Belt Technologies, Inc.
2828 Liberty Ave.
Suite 100
Pittsburgh,  PA  15222
Correspondent Contact RICHARD G CONFER
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/02/2012
Decision Date 11/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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