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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 K140754
Device Name COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
Applicant
COOPER SURGICAL, INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Applicant Contact TIM LOHNES
Correspondent
COOPER SURGICAL, INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Correspondent Contact TIM LOHNES
Regulation Number884.1630
Classification Product Code
HEX  
Date Received03/26/2014
Decision Date 10/23/2014
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
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