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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K150633
Device Name ULTRA Telescopes
Applicant
Olympus Winter & Ibe GmbH
Kuehnstrasse 61
Hamburg,  DE 22045
Applicant Contact KATHARINA SCHNACKENBURG
Correspondent
Olympus Corportion of the Americas
3500 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact SHERI L. MUSGNUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
HET   NMH  
Date Received03/11/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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