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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 Interlaminal
510(k) Number K030241
Device Name MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
Applicant
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Applicant Contact DEAN CIPORKIN
Correspondent
Blackstone Medical, Inc.
90 Brooksdale Dr.
Springfield,  MA  01104
Correspondent Contact DEAN CIPORKIN
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received01/23/2003
Decision Date 02/21/2003
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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