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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 K183020
Device Name Endosee System
Applicant
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Applicant Contact Roaida Johnson
Correspondent
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Correspondent Contact Roaida Johnson
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
FAJ  
Date Received11/01/2018
Decision Date 01/31/2019
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
Recalls CDRH Recalls
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