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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 K050768
Device Name ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
Applicant
Hamilton Thorne Biosciences
181 Elliott St.
100 Cummings Center-Suite 465e
Beverly,  MA  01915
Applicant Contact DIARMAID H DOUGLAS-HAMILTON
Correspondent
Hamilton Thorne Biosciences
181 Elliott St.
100 Cummings Center-Suite 465e
Beverly,  MA  01915
Correspondent Contact DIARMAID H DOUGLAS-HAMILTON
Regulation Number884.6200
Classification Product Code
MRX  
Date Received03/25/2005
Decision Date 04/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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