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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 K030197
Device Name BLACKSTONE POSTERIOR CERVICAL 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 Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received01/21/2003
Decision Date 06/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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