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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K092433
Device Name DYSIS
Applicant
Forth Photonics Hellas SA
690 Canton St., Suite 302
Canton,  MA  02090
Applicant Contact JUAN CARLOS SERNA
Correspondent
Forth Photonics Hellas SA
690 Canton St., Suite 302
Canton,  MA  02090
Correspondent Contact JUAN CARLOS SERNA
Regulation Number884.1630
Classification Product Code
HEX  
Date Received08/07/2009
Decision Date 03/10/2011
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
Predetermined Change
Control Plan Authorized		 No
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