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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 K070845
Device Name SOUNMED COLOPOSCOPE COLPO-99/99PLUS
Applicant
Sounmed, Inc.
6800 NW 77th Court
Miami,  FL  33166
Applicant Contact RUBEN OLIVARES
Correspondent
Sounmed, Inc.
6800 NW 77th Court
Miami,  FL  33166
Correspondent Contact RUBEN OLIVARES
Regulation Number884.1630
Classification Product Code
HEX  
Date Received03/27/2007
Decision Date 10/12/2007
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
Predetermined Change
Control Plan Authorized		 No
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