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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, assisted reproduction laser
510(k) Number K063636
Device Name ZILOS-TK
Applicant
HAMILTON THORNE BIOSCIENCES
100 CUMMINGS CENTER,
SUITE 465E
BEVERLY,  MA  01915
Applicant Contact DOUGLAS HAMILTON
Correspondent
HAMILTON THORNE BIOSCIENCES
100 CUMMINGS CENTER,
SUITE 465E
BEVERLY,  MA  01915
Correspondent Contact DOUGLAS HAMILTON
Regulation Number884.6200
Classification Product Code
MRX  
Date Received12/07/2006
Decision Date 04/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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