FDA 510(k) Application Details - K003911

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K003911
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant TERRAY CORP.
49 JACKSON LANE
PINE GROVE INDUSTRIAL PARK
ARNPRIOR, ONTARIO K7S 3G8 CA
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Contact STEVE WANG
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 12/19/2000
Decision Date 03/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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