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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name system, assisted reproduction laser
De Novo Number DEN040009
510(K) Number K040045
Device Name HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)
Requester
hamilton thorne biosciences
100 cummings center
suite 465e
beverly,  MA  01915
Contact diarmaid douglas-hamilton
Regulation Number884.6200
Classification Product Code
MRX  
Date Received08/25/2004
Decision Date 11/04/2004
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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