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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K132384
Device Name U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
Applicant
ENDOSEC CORPORATION
4546 EL CAMINO REAL, STE 215
LOS ALTOS,  CA  94022
Applicant Contact PIN YU
Correspondent
ENDOSEC CORPORATION
4546 EL CAMINO REAL, STE 215
LOS ALTOS,  CA  94022
Correspondent Contact PIN YU
Regulation Number884.1690
Classification Product Code
HIH  
Date Received07/31/2013
Decision Date 07/02/2014
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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