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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 K080394
Device Name BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
Applicant
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Applicant Contact WHITNEY G TORNING
Correspondent
BLACKSTONE MEDICAL, INC.
1211 HAMBURG TURNPIKE
SUITE 300
WAYNE,  NJ  07470
Correspondent Contact WHITNEY G TORNING
Regulation Number888.3050
Classification Product Code
KWP  
Date Received02/13/2008
Decision Date 03/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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