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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 K180496
Device Name TruClear Elite Hysteroscope
Applicant
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Applicant Contact Gail Yaeker-Daunis
Correspondent
Covidien
60 Middletown Ave.
North Haven,  CT  06473
Correspondent Contact Gail Yaeker-Daunis
Regulation Number884.1690
Classification Product Code
HIH  
Date Received02/26/2018
Decision Date 08/29/2018
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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