FDA 510(k) Application Details - K011292

Device Classification Name

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510(K) Number K011292
Device Name ZIEHM VISION
Applicant ZIEHM INTERNATIONAL, INC.
4181 LATHAM ST.
RIVERSIDE, CA 92501 US
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Contact LANELL SAMANIEGO
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Regulation Number

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Classification Product Code OWB
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Date Received 04/30/2001
Decision Date 06/20/2001
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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