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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 K033961
Device Name ALTIUS OCT SYSTEM
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618 -2402
Applicant Contact WENDY SPIELBERGER
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618 -2402
Correspondent Contact WENDY SPIELBERGER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/22/2003
Decision Date 04/14/2004
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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