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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 K213207
Device Name Sheath, Stopcock Accessory
Applicant
Olympus Winter & Ibe GmbH
Kuehnstr, 61
Hamburg,  DE 22045
Applicant Contact Katharina Campbell
Correspondent
Olympus Corporation of the Americas (Oca)
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Jonathan Gilbert
Regulation Number884.1690
Classification Product Code
HIH  
Date Received09/29/2021
Decision Date 12/22/2021
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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