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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 K100595
Device Name ECLERIS MICROSTAR COLPOSCOPE
Applicant
Ecleris USA
12225 World Trade Dr., Suite K
San Diego,  CA  92128
Applicant Contact RAYMOND J KELLY IV
Correspondent
Ecleris USA
12225 World Trade Dr., Suite K
San Diego,  CA  92128
Correspondent Contact RAYMOND J KELLY IV
Regulation Number884.1630
Classification Product Code
HEX  
Date Received03/02/2010
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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