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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 K022605
Device Name BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
Applicant
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Applicant Contact ALAN LOMBARDO
Correspondent
Blackstone Medical, Inc.
90 Brookdale Dr.
Springfield,  MA  01104
Correspondent Contact ALAN LOMBARDO
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/06/2002
Decision Date 08/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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