FDA 510(k) Application Details - K972766

Device Classification Name System, X-Ray, Stationary

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510(K) Number K972766
Device Name System, X-Ray, Stationary
Applicant OCTOSTOP, INC.
CASIER POSTAL 1476
SUCC. ST-LAURENT
MONTREAL, QC. H4L 4Z1 CA
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Contact JEAN A VENZINA
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 07/24/1997
Decision Date 08/14/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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