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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K030595
Device Name BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
Applicant
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Applicant Contact DEAN E CIPORKIN
Correspondent
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Correspondent Contact DEAN E CIPORKIN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received02/25/2003
Decision Date 04/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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