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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 K061306
Device Name CO-1000 COLPOSCOPE, MULTIPLE
Applicant
GYNEX CORP.
2789 152ND AVE., NE
REDMOND,  WA  98052
Applicant Contact KAREN CARDIFF
Correspondent
GYNEX CORP.
2789 152ND AVE., NE
REDMOND,  WA  98052
Correspondent Contact KAREN CARDIFF
Regulation Number884.1630
Classification Product Code
HEX  
Date Received05/10/2006
Decision Date 08/07/2006
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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