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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 K073654
Device Name BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
Applicant
Blackstone Medical, Inc.
1211 Hamburg Tpke.,
Suite 300
Wayne,  NJ  07470
Applicant Contact WHITNEY G TORNING
Correspondent
Blackstone Medical, Inc.
1211 Hamburg Tpke.,
Suite 300
Wayne,  NJ  07470
Correspondent Contact WHITNEY G TORNING
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/26/2007
Decision Date 01/24/2008
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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